Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Purpose

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

Conditions

  • Advanced Malignant Solid Neoplasm
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Locally Advanced Malignant Solid Neoplasm
  • Malignant Female Reproductive System Neoplasm
  • Metastatic HER2-Negative Breast Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Endometrial Carcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Malignant Female Reproductive System Neoplasm
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Unresectable HER2-Negative Breast Carcinoma
  • Unresectable Malignant Solid Neoplasm

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Inclusion Criteria:

- Patient must have measurable disease

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
between 0-2 OR patient must have Lansky performance status of >= 50% or Karnofsky
performance status of >= 50%

- Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as
assessed by the enrolling provider

- All patients must have sequencing results available from a National Cancer Institute
(NCI) credentialed Designated Laboratory (DL)

- Patients must have locally advanced or advanced histologically documented solid
tumors requiring therapy and meet one of the following criteria:

- Patients must have progressed on at least one line of standard systemic therapy
OR

- Patients whose disease has no standard treatment that has been shown to prolong
overall survival

- Patient must meet one of the following requirements:

- Patients 18 years and older who have tumor amenable to minimal risk
image-guided or direct vision biopsy and must be willing and able to undergo a
tumor biopsy to obtain samples for research if the patient is to enroll in a
ComboMATCH treatment trial OR

- Patients 18 years and older who do not have disease that is biopsiable at
minimal risk to the patient must confirm availability of an archival tumor
tissue specimen for submission for research if the patient enrolls to a
ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:

- Tissue must have been collected within 12 months prior to registration to
the EAY191 Registration Trial

- Patient must not have had a Response Evaluation Criteria in Solid Tumors
(RECIST) response (complete response [CR] or partial response [PR]) to any
intervening therapy after collection of the tissue

- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be
available OR

- Patients under 18 years old must confirm availability of an archival tumor
tissue specimen for submission for research if patient enrolls to a ComboMATCH
Treatment Trial. This tumor tissue must meet the following criteria:

- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be
available

- NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection
and management instructions. Performance of the mandatory research biopsy or
submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection
and submission of the blood specimens for the integrated studies will be
performed under the consent authority of the specific treatment trial protocol
to which the patient is registered. No procedures to collect specimens for
research only are to be performed for patients registered to the EAY191
Registration Trial only

- NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If
patient is found to not be eligible for the assigned ComboMATCH Treatment Trial,
indication of ineligibility will trigger re-evaluation and potential assignment to
another Treatment Trial

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
EAY191-A2 (Cohort 1, Arm A)
Cohort 1, Arm A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
  • Drug: Alpelisib
    Given PO
    Other names:
    • BYL 719
    • BYL-719
    • BYL719
    • Phosphoinositide 3-kinase Inhibitor BYL719
    • Piqray
    • VIJOICE
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Olaparib
    Given PO
    Other names:
    • AZD 2281
    • AZD-2281
    • AZD2281
    • KU 0059436
    • KU-0059436
    • KU0059436
    • Lynparza
    • Olanib
    • Olaparix
    • PARP Inhibitor AZD2281
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
Experimental
EAY191-A2 (Cohort 2, Arm B)
Cohort 2, Arm B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
  • Drug: Alpelisib
    Given PO
    Other names:
    • BYL 719
    • BYL-719
    • BYL719
    • Phosphoinositide 3-kinase Inhibitor BYL719
    • Piqray
    • VIJOICE
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Olaparib
    Given PO
    Other names:
    • AZD 2281
    • AZD-2281
    • AZD2281
    • KU 0059436
    • KU-0059436
    • KU0059436
    • Lynparza
    • Olanib
    • Olaparix
    • PARP Inhibitor AZD2281
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
Experimental
EAY191-A2 (Cohort 2, Arm C)
Cohort 2, Arm C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Olaparib
    Given PO
    Other names:
    • AZD 2281
    • AZD-2281
    • AZD2281
    • KU 0059436
    • KU-0059436
    • KU0059436
    • Lynparza
    • Olanib
    • Olaparix
    • PARP Inhibitor AZD2281
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
Experimental
EAY191-A2 (Cohort 3, Arm D)
Cohort 3, Arm D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
  • Drug: Alpelisib
    Given PO
    Other names:
    • BYL 719
    • BYL-719
    • BYL719
    • Phosphoinositide 3-kinase Inhibitor BYL719
    • Piqray
    • VIJOICE
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Drug: Olaparib
    Given PO
    Other names:
    • AZD 2281
    • AZD-2281
    • AZD2281
    • KU 0059436
    • KU-0059436
    • KU0059436
    • Lynparza
    • Olanib
    • Olaparix
    • PARP Inhibitor AZD2281
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
Experimental
EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib)
Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Palbociclib
    Given PO
    Other names:
    • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
    • Ibrance
    • PD 0332991
    • PD 332991
    • PD 991
    • PD-0332991
    • PD0332991
Experimental
EAY191-A3 Monotherapy Cohort 1 (binimetinib)
Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
  • Drug: Binimetinib
    Given PO
    Other names:
    • ARRY 162
    • ARRY 438162
    • ARRY-162
    • ARRY-438162
    • ARRY162
    • ARRY438162
    • MEK 162
    • MEK-162
    • MEK162
    • Mektovi
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
Experimental
EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations)
Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or a FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Drug: Fluorouracil
    Given IV
    Other names:
    • 5 Fluorouracil
    • 5 Fluorouracilum
    • 5 FU
    • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    • 5-Fluorouracil
    • 5-Fluracil
    • 5-Fu
    • 5FU
    • AccuSite
    • Carac
    • Fluoro Uracil
    • Fluouracil
    • Flurablastin
    • Fluracedyl
    • Fluracil
    • Fluril
    • Fluroblastin
    • Ribofluor
    • Ro 2-9757
    • Ro-2-9757
  • Drug: Leucovorin
    Given IV
    Other names:
    • Folinic acid
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Drug: Oxaliplatin
    Given IV
    Other names:
    • 1-OHP
    • Ai Heng
    • Aiheng
    • Dacotin
    • Dacplat
    • Diaminocyclohexane Oxalatoplatinum
    • Eloxatin
    • Eloxatine
    • Elplat
    • JM 83
    • JM-83
    • JM83
    • Oxalatoplatin
    • Oxalatoplatinum
    • RP 54780
    • RP-54780
    • RP54780
    • SR 96669
    • SR-96669
    • SR96669
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
Experimental
EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations)
Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated
  • Drug: Binimetinib
    Given PO
    Other names:
    • ARRY 162
    • ARRY 438162
    • ARRY-162
    • ARRY-438162
    • ARRY162
    • ARRY438162
    • MEK 162
    • MEK-162
    • MEK162
    • Mektovi
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Drug: Fluorouracil
    Given IV
    Other names:
    • 5 Fluorouracil
    • 5 Fluorouracilum
    • 5 FU
    • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    • 5-Fluorouracil
    • 5-Fluracil
    • 5-Fu
    • 5FU
    • AccuSite
    • Carac
    • Fluoro Uracil
    • Fluouracil
    • Flurablastin
    • Fluracedyl
    • Fluracil
    • Fluril
    • Fluroblastin
    • Ribofluor
    • Ro 2-9757
    • Ro-2-9757
  • Drug: Leucovorin
    Given IV
    Other names:
    • Folinic acid
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Drug: Oxaliplatin
    Given IV
    Other names:
    • 1-OHP
    • Ai Heng
    • Aiheng
    • Dacotin
    • Dacplat
    • Diaminocyclohexane Oxalatoplatinum
    • Eloxatin
    • Eloxatine
    • Elplat
    • JM 83
    • JM-83
    • JM83
    • Oxalatoplatin
    • Oxalatoplatinum
    • RP 54780
    • RP-54780
    • RP54780
    • SR 96669
    • SR-96669
    • SR96669
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
Experimental
EAY191-E4 (taxane therapy)
Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Nilotinib Hydrochloride Monohydrate
    Given PO
    Other names:
    • AMN 107
    • AMN-107
    • AMN107
    • Nilotinib Monohydrochloride Monohydrate
    • Tasigna
  • Drug: Paclitaxel
    Given PO or IV
    Other names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat
Experimental
EAY191-E5 Cohort I Arm A (sotorasib, panitumumab)
Patients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Biological: Panitumumab
    Given IV
    Other names:
    • ABX-EGF
    • ABX-EGF Monoclonal Antibody
    • ABX-EGF, Clone E7.6.3
    • E7.6.3
    • Human IgG2K Monoclonal Antibody
    • MoAb ABX-EGF
    • MoAb E7.6.3
    • Monoclonal Antibody ABX-EGF
    • Monoclonal Antibody E7.6.3
    • Vectibix
  • Drug: Sotorasib
    Given PO
    Other names:
    • AMG 510
    • AMG-510
    • AMG510
    • Lumakras
    • Lumykras
Active Comparator
EAY191-E5 Cohort I Arm B (sotorasib)
Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Sotorasib
    Given PO
    Other names:
    • AMG 510
    • AMG-510
    • AMG510
    • Lumakras
    • Lumykras
Experimental
EAY191-E5 Cohort II (sotorasib)
Patients receive combination therapy as in EAY191-E5 Arm A.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Biological: Panitumumab
    Given IV
    Other names:
    • ABX-EGF
    • ABX-EGF Monoclonal Antibody
    • ABX-EGF, Clone E7.6.3
    • E7.6.3
    • Human IgG2K Monoclonal Antibody
    • MoAb ABX-EGF
    • MoAb E7.6.3
    • Monoclonal Antibody ABX-EGF
    • Monoclonal Antibody E7.6.3
    • Vectibix
  • Drug: Sotorasib
    Given PO
    Other names:
    • AMG 510
    • AMG-510
    • AMG510
    • Lumakras
    • Lumykras
Experimental
EAY191-N2 Cohort I (Arm I) (NF1 mutations)
Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.
  • Drug: Binimetinib
    Given PO
    Other names:
    • ARRY 162
    • ARRY 438162
    • ARRY-162
    • ARRY-438162
    • ARRY162
    • ARRY438162
    • MEK 162
    • MEK-162
    • MEK162
    • Mektovi
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Drug: Fulvestrant
    Given IM
    Other names:
    • Faslodex
    • Faslodex(ICI 182,780)
    • ICI 182,780
    • ICI 182780
    • ICI-182780
    • ICI182780
    • ZD 9238
    • ZD-9238
    • ZD9238
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
Experimental
EAY191-N2 Cohort I (Arm II) (NF1 mutations)
Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Drug: Fulvestrant
    Given IM
    Other names:
    • Faslodex
    • Faslodex(ICI 182,780)
    • ICI 182,780
    • ICI 182780
    • ICI-182780
    • ICI182780
    • ZD 9238
    • ZD-9238
    • ZD9238
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
Experimental
EAY191-N2 Cohort II (NF1 mutations)
Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.
  • Drug: Binimetinib
    Given PO
    Other names:
    • ARRY 162
    • ARRY 438162
    • ARRY-162
    • ARRY-438162
    • ARRY162
    • ARRY438162
    • MEK 162
    • MEK-162
    • MEK162
    • Mektovi
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Scan
    Undergo bone scan
    Other names:
    • Bone Scintigraphy
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Drug: Fulvestrant
    Given IM
    Other names:
    • Faslodex
    • Faslodex(ICI 182,780)
    • ICI 182,780
    • ICI 182780
    • ICI-182780
    • ICI182780
    • ZD 9238
    • ZD-9238
    • ZD9238
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
Experimental
EAY191-N4 Arm I (RAS pathway mutations)
Patients receive selumetinib PO BID and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Marrow Aspiration
    Undergo bone marrow aspiration
  • Procedure: Bone Marrow Biopsy
    Undergo bone marrow biopsy
    Other names:
    • Biopsy of Bone Marrow
    • Biopsy, Bone Marrow
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Procedure: Mutation Carrier Screening
    Undergo tumor mutational screening
  • Drug: Olaparib
    Given PO
    Other names:
    • AZD 2281
    • AZD-2281
    • AZD2281
    • KU 0059436
    • KU-0059436
    • KU0059436
    • Lynparza
    • Olanib
    • Olaparix
    • PARP Inhibitor AZD2281
  • Drug: Selumetinib Sulfate
    Given PO
    Other names:
    • AZD-6244 Hydrogen Sulfate
    • AZD6244 Hydrogen Sulfate
    • AZD6244 Hydrogen Sulphate
    • Koselugo
    • Selumetinib Sulphate
Active Comparator
EAY191-N4 Arm II (RAS pathway mutations)
Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Bone Marrow Aspiration
    Undergo bone marrow aspiration
  • Procedure: Bone Marrow Biopsy
    Undergo bone marrow biopsy
    Other names:
    • Biopsy of Bone Marrow
    • Biopsy, Bone Marrow
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Procedure: Mutation Carrier Screening
    Undergo tumor mutational screening
  • Drug: Selumetinib Sulfate
    Given PO
    Other names:
    • AZD-6244 Hydrogen Sulfate
    • AZD6244 Hydrogen Sulfate
    • AZD6244 Hydrogen Sulphate
    • Koselugo
    • Selumetinib Sulphate
Active Comparator
EAY191-N5 Arm I (neratinib maleate)
Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Drug: Neratinib Maleate
    Given PO
    Other names:
    • 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1)
    • HKI-272 Maleate
    • NERATINIB MALEATE ANHYDROUS
    • Nerlynx
Experimental
EAY191-N5 Arm II (neratinib maleate,palbociclib)
Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Procedure: Echocardiography Test
    Undergo ECHO
    Other names:
    • EC
    • Echocardiography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • Gated Heart Pool Scan
    • MUGA
    • MUGA Scan
    • Multi-Gated Acquisition Scan
    • Radionuclide Ventriculogram Scan
    • Radionuclide Ventriculography
    • RNV Scan
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Drug: Neratinib Maleate
    Given PO
    Other names:
    • 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1)
    • HKI-272 Maleate
    • NERATINIB MALEATE ANHYDROUS
    • Nerlynx
  • Drug: Palbociclib
    Given PO
    Other names:
    • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
    • Ibrance
    • PD 0332991
    • PD 332991
    • PD 991
    • PD-0332991
    • PD0332991
Experimental
EAY191-S3 (activating AKT mutation)
Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up.
  • Procedure: Biopsy Procedure
    Undergo biopsy
    Other names:
    • Biopsy
    • BIOPSY_TYPE
    • Bx
  • Procedure: Biospecimen Collection
    Undergo blood collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • Diagnostic CAT Scan
    • Diagnostic CAT Scan Service Type
    • tomography
  • Drug: Ipatasertib
    Given PO
    Other names:
    • GDC 0068
    • GDC-0068
    • GDC0068
    • RG 7440
    • RG-7440
    • RG7440
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Drug: Paclitaxel
    Given PO or IV
    Other names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Site Public Contact
gingerreeves@uabmc.edu

University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36688
Contact:
Site Public Contact
251-445-9870
pfrancisco@usouthal.edu

Alaska Women's Cancer Care
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

CTCA at Western Regional Medical Center
Goodyear, Arizona 85338
Contact:
Site Public Contact
623-207-3000

Kingman Regional Medical Center
Kingman, Arizona 86401
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas 72401
Contact:
Site Public Contact
870-936-7066
Emily.Carvell@bmhcc.org

PCR Oncology
Arroyo Grande, California 93420
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Mercy Cancer Center - Carmichael
Carmichael, California 95608
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy San Juan Medical Center
Carmichael, California 95608
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

UC San Diego Health System - Encinitas
Encinitas, California 92024
Contact:
Site Public Contact
760-536-7700

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California 90025
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Cedars Sinai Medical Center
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965

Children's Hospital of Orange County
Orange, California 92868
Contact:
Site Public Contact
714-509-8646
oncresearch@choc.org

Saint Joseph Hospital - Orange
Orange, California 92868
Contact:
Site Public Contact
714-734-6220

Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Mercy Cancer Center - Rocklin
Rocklin, California 95765
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy Cancer Center - Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

UC San Diego Medical Center - Hillcrest
San Diego, California 92103
Contact:
Site Public Contact
rhabbaba@health.ucsd.edu

Sharp Memorial Hospital
San Diego, California 92123
Contact:
Site Public Contact
858-939-5062
cathy.wood@sharp.com

UCSF Medical Center-Mission Bay
San Francisco, California 94158
Contact:
Site Public Contact
877-827-3222
cancertrials@ucsf.edu

Saint John's Cancer Institute
Santa Monica, California 90404
Contact:
Site Public Contact
310-582-7448

Woodland Memorial Hospital
Woodland, California 95695
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

UCHealth Greeley Hospital
Greeley, Colorado 80631
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Medical Center of the Rockies
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Contact:
Site Public Contact
954-461-2180

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647

Broward Health Medical Center
Fort Lauderdale, Florida 33316
Contact:
Site Public Contact
302-651-5572
Allison.bruce@nemours.org

UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610
Contact:
Site Public Contact
352-273-8010
cancer-center@ufl.edu

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
Contact:
Site Public Contact
305-243-2647

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida 33181
Contact:
Site Public Contact
kginnity@med.miami.edu

UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
Contact:
Site Public Contact
305-243-2647

Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-524-6115
i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-532-0315

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548

Straub Clinic and Hospital
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-522-4333

University of Hawaii Cancer Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-586-2979

Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-531-8521

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Contact:
Site Public Contact
808-983-6090

Hawaii Cancer Care - Westridge
‘Aiea, Hawaii 96701
Contact:
Site Public Contact
808-539-2273
info@hawaiicancercare.com

Pali Momi Medical Center
‘Aiea, Hawaii 96701
Contact:
Site Public Contact
808-486-6000

The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii 96706
Contact:
Site Public Contact
rohta@queens.org

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

SIH Cancer Institute
Carterville, Illinois 62918
Contact:
Site Public Contact
618-985-3333
clinical.research@sih.net

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia, Illinois 62801
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Mount Sinai Hospital Medical Center
Chicago, Illinois 60608
Contact:
Site Public Contact
773-257-5960
suhi@sinai.org

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204

University of Illinois
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046

University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Contact:
Site Public Contact
773-296-5360

AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Contact:
Site Public Contact
630-929-6129
advocateresearch@advocate.com

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Illinois CancerCare-Dixon
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800

Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Contact:
Site Public Contact
630-275-1270
Barbara.barhamand@advocatehealth.com

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Advocate Sherman Hospital
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109

Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
Contact:
Site Public Contact
312-695-1102

Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
Contact:
Site Public Contact
312-695-1102

Ingalls Memorial Hospital
Harvey, Illinois 60426
Contact:
Site Public Contact
708-915-4673
clinicaltrials@ingalls.org

Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Contact:
Site Public Contact
cancertrials@northwestern.edu

AMG Libertyville - Oncology
Libertyville, Illinois 60048
Contact:
Site Public Contact
630-929-6129
advocateresearch@advocatehealth.com

Condell Memorial Hospital
Libertyville, Illinois 60048
Contact:
Site Public Contact
630-929-6129
advocateresearch@advocatehealth.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Carle BroMenn Medical Center
Normal, Illinois 61761
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Carle Cancer Institute Normal
Normal, Illinois 61761
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622

Northwestern Medicine Orland Park
Orland Park, Illinois 60462
Contact:
Site Public Contact
nctnprogram_rhlccc@northwestern.edu

University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Mercyhealth Cancer Institute - Rockford
Rockford, Illinois 61114
Contact:
Site Public Contact
815-971-5858
oncologyclinicaltrials@mhemail.org

Memorial Hospital East
Shiloh, Illinois 62269
Contact:
Site Public Contact
314-747-9912
dschwab@wustl.edu

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Springfield Memorial Hospital
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Illinois CancerCare - Washington
Washington, Illinois 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-241-3305

Mercy Hospital
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673

Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305

UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305

UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
Contact:
Site Public Contact
515-241-3305

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379

East Jefferson General Hospital
Metairie, Louisiana 70006
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-842-8084
Elisemarie.curry@ochsner.org

Harold Alfond Center for Cancer Care
Augusta, Maine 04330
Contact:
Site Public Contact
207-626-4855

Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005

MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine 04106
Contact:
Site Public Contact
207-396-8670
clinicalresearch@mainehealth.org

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100

National Institutes of Health Clinical Center
Bethesda, Maryland 20892
Contact:
Site Public Contact
800-411-1222

UPMC Western Maryland
Cumberland, Maryland 21502
Contact:
Site Public Contact
240-964-1400

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Site Public Contact
617-636-5000
ContactUsCancerCenter@TuftsMedicalCenter.org

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Site Public Contact
877-442-3324

Baystate Medical Center
Springfield, Massachusetts 01199
Contact:
Site Public Contact
413-794-3565
tamara.wrenn@baystatehealth.org

Tufts Medical Center Cancer Center Stoneham
Stoneham, Massachusetts 02180
Contact:
Site Public Contact
617-636-3264
NCCCR@Tuftsmedicalcenter.org

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
CancerAnswerLine@med.umich.edu

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan 48116
Contact:
Site Public Contact
800-865-1125

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan 49829
Contact:
Site Public Contact
920-433-8889
WI_research_admin@hshs.org

Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan 48336
Contact:
Site Public Contact
248-551-7695

Cancer Hematology Centers - Flint
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan 49009
Contact:
Site Public Contact
574-647-7370

Beacon Kalamazoo
Kalamazoo, Michigan 49048
Contact:
Site Public Contact
574-647-7370

University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan 48044
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Michigan Healthcare Professionals Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

MyMichigan Medical Center Tawas
Tawas City, Michigan 48764
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308

Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Sandstone
Sandstone, Minnesota 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Gulfport Memorial Hospital
Gulfport, Mississippi 39502
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Saint Luke's Hospital
Chesterfield, Missouri 63017
Contact:
Site Public Contact
314-205-6936

Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Phelps Health Delbert Day Cancer Institute
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Contact:
Site Public Contact
816-271-7937
Trisha.England2@mymlc.com

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital South
St Louis, Missouri 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Siteman Cancer Center-South County
St Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
St Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital Saint Louis
St Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Logan Health Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Renown Regional Medical Center
Reno, Nevada 89502
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Hunterdon Medical Center
Flemington, New Jersey 08822
Contact:
Site Public Contact
908-237-2330

Saint Barnabas Medical Center
Livingston, New Jersey 07039
Contact:
Site Public Contact
973-322-2934
joanne.loeb@rwjbh.org

Monmouth Medical Center
Long Branch, New Jersey 07740
Contact:
Site Public Contact
732-923-6564
mary.danish@rwjbh.org

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356

Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481
Siby.Varughese@rwjbh.org

Community Medical Center
Toms River, New Jersey 08755
Contact:
Site Public Contact
732-557-8294
Lennette.Gonzales@rwjbh.org

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Memorial Sloan Kettering Commack
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

NYU Langone Hospital - Long Island
Mineola, New York 11501
Contact:
Site Public Contact
212-263-4432
cancertrials@nyulangone.org

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
Contact:
Site Public Contact
CancerTrials@nyulangone.org

Mount Sinai Hospital
New York, New York 10029
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

State University of New York Upstate Medical University
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476

Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
The Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Cone Health MedCenter Asheboro
Asheboro, North Carolina 27205
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina 27215
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
Contact:
Site Public Contact
919-587-9084
jfields@cancersmoc.com

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
Contact:
Site Public Contact
919-587-9084
jfields@cancersmoc.com

Cone Health Cancer Center
Greensboro, North Carolina 27403
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina 27410
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Hayworth Cancer Center
High Point, North Carolina 27262
Contact:
Site Public Contact
336-802-2500

Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
Contact:
Site Public Contact
910-587-9084
jfields@cancersmoc.com

Duke Women's Cancer Care Raleigh
Raleigh, North Carolina 27607
Contact:
Site Public Contact
919-785-4878

Annie Penn Memorial Hospital
Reidsville, North Carolina 27320
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Aultman Health Foundation
Canton, Ohio 44710
Contact:
Site Public Contact
330-363-7274
ClinicalReserachDept@aultman.com

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
Jeffh@columbusccop.org

Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Mount Carmel East Hospital
Columbus, Ohio 43213
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Riverside Methodist Hospital
Columbus, Ohio 43214
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Grant Medical Center
Columbus, Ohio 43215
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Doctors Hospital
Columbus, Ohio 43228
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Grady Memorial Hospital
Delaware, Ohio 43015
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Columbus Oncology and Hematology Associates
Dublin, Ohio 43016
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Dublin Methodist Hospital
Dublin, Ohio 43016
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Fairfield Medical Center
Lancaster, Ohio 43130
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

OhioHealth Mansfield Hospital
Mansfield, Ohio 44903
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

OhioHealth Marion General Hospital
Marion, Ohio 43302
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Memorial Hospital
Marysville, Ohio 43040
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Knox Community Hospital
Mount Vernon, Ohio 43050
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Licking Memorial Hospital
Newark, Ohio 43055
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health - Perrysburg Hospital
Perrysburg, Ohio 43551
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Southern Ohio Medical Center
Portsmouth, Ohio 45662
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Springfield Regional Cancer Center
Springfield, Ohio 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Springfield Regional Medical Center
Springfield, Ohio 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health - Saint Anne Hospital
Toledo, Ohio 43623
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Saint Ann's Hospital
Westerville, Ohio 43081
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

UPMC Altoona
Altoona, Pennsylvania 16601
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900

Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Riddle Memorial Hospital
Media, Pennsylvania 19063
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-864-7716
ClinicalResearchServices@upmc.edu

Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
Contact:
Site Public Contact
412-647-2811

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454

Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania 18840
Contact:
Site Public Contact
800-836-0388

Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Women and Infants Hospital
Providence, Rhode Island 02905
Contact:
Site Public Contact
401-274-1122

Roger Williams Medical Center
Providence, Rhode Island 02908
Contact:
Site Public Contact
401-456-2698
fdallesandro@chartercare.org

Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Richland Hospital
Columbia, South Carolina 29203
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Saint Francis Hospital
Greenville, South Carolina 29601
Contact:
Site Public Contact
864-603-6234
Heather_Rich@bshsi.org

BI-LO Charities Children's Cancer Center
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Saint Francis Cancer Center
Greenville, South Carolina 29607
Contact:
Site Public Contact
864-603-6234
Heather_Rich@bshsi.org

Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Rapid City Regional Hospital
Rapid City, South Dakota 57701
Contact:
Site Public Contact
605-755-2370
research@monument.health

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee 37660
Contact:
Site Public Contact
423-431-5654
charles.mays@balladhealth.org

Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
Contact:
Site Public Contact
800-811-8480

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

Hendrick Medical Center
Abilene, Texas 79601
Contact:
Site Public Contact
325-670-6340

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

Lyndon Baines Johnson General Hospital
Houston, Texas 77026-1967
Contact:
Site Public Contact
713-566-5000

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Scott and White Memorial Hospital
Temple, Texas 76508
Contact:
Site Public Contact
254-724-5407

University of Virginia Cancer Center
Charlottesville, Virginia 22908
Contact:
Site Public Contact
434-243-6303
uvacancertrials@hscmail.mcc.virginia.edu

Inova Schar Cancer Institute
Fairfax, Virginia 22031
Contact:
Site Public Contact
703-720-5210
Stephanie.VanBebber@inova.org

Inova Fairfax Hospital
Falls Church, Virginia 22042
Contact:
Site Public Contact
703-208-6650
Stephanie.VanBebber@inova.org

Henrico Doctor's Hospital
Richmond, Virginia 23229
Contact:
Site Public Contact
804-591-4152

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
804-628-6430
CTOclinops@vcu.edu

Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24033
Contact:
Site Public Contact
540-985-8510

VCU Community Memorial Health Center
South Hill, Virginia 23970
Contact:
Site Public Contact
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Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
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Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
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Providence Regional Cancer System-Lacey
Lacey, Washington 98503
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360-412-8958
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Valley Medical Center
Renton, Washington 98055
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425-228-3440
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Swedish Medical Center-First Hill
Seattle, Washington 98122
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206-215-2343
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Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
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509-897-5993
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Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
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304-399-6566
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West Virginia University Healthcare
Morgantown, West Virginia 26506
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304-293-7374
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ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
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ThedaCare Regional Medical Center - Appleton
Appleton, Wisconsin 54911
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Duluth Clinic Ashland
Ashland, Wisconsin 54806
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218-786-3308
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ThedaCare Cancer Care - Berlin
Berlin, Wisconsin 54923
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Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
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414-302-2304
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Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
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800-782-8581
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Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
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Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
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Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
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Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
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Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
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Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin 53548
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Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
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Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
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University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
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Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
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Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
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Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
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Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
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Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
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ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
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ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin 54956
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ThedaCare Cancer Care - New London
New London, Wisconsin 54961
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Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
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ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
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Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
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ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin 54904
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Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
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Aurora Cancer Care-Racine
Racine, Wisconsin 53406
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
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Shawano, Wisconsin 54166
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Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
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Sheboygan Physicians Group
Sheboygan, Wisconsin 53081
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Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
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Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
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Aurora Medical Center in Summit
Summit, Wisconsin 53066
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Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
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UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
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262-928-5539
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ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin 54981
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Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
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414-302-2304
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Aurora West Allis Medical Center
West Allis, Wisconsin 53227
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Marshfield Medical Center - Weston
Weston, Wisconsin 54476
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Puerto Rico Hematology Oncology Group
Bayamón, Puerto Rico 00961
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787-780-2865

Doctors Cancer Center
Manatí, Puerto Rico 00674
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787-621-4397

Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
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ecog.rss@jimmy.harvard.edu

PROncology
San Juan, Puerto Rico 00927
Contact:
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787-919-7919
info@PRoncology.com

More Details

NCT ID
NCT05564377
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVE: I. To register, allocate, and assign patients to ComboMATCH treatment trials. SECONDARY OBJECTIVES: I. To evaluate the rate of positive outcomes in defined cohorts within treatment trials of treatment combinations including targeted therapies for molecularly defined populations, and also in the subset of treatment trials where the treatments are supported by in vivo models. II. To perform quality control of the patients registered in the form of pathological confirmation of disease and sub-type to confirm diagnosis and treatment arm allocation. SECONDARY CORRELATIVE OBJECTIVES: I. Assess the concordance of the central molecular characterization of the pre-treatment biopsy samples with the genetic readouts from the Designated Laboratories (DLs) for patients enrolled on the ComboMATCH treatment trials. II. To assess how the registration diagnostic tumor mutation profile and pre-treatment biopsy profile compare to the circulating tumor-derived deoxyribonucleic acid (ctDNA) mutation profile from plasma. EXPLORATORY OBJECTIVE: I. Assess association between ComboMATCH treatment trials outcomes (positive or negative) with the type of rationale for the selected drug combinations and the type of rationale for the gene variant/combination for selection (e.g., whether the trial was based on targeted therapies for molecularly defined populations, those that were supported by in vivo models, and those that were supported by empiric clinical data). OUTLINE: REGISTRATION: Patients undergo tumor mutational screening of previously-collected tumor samples for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing. Patients who are 18 years or older and have biopsiable disease undergo a new biopsy for research purposes prior to initiating treatment on the ComboMATCH treatment trial. TREATMENT: Patients with mutations targeted to investigational combination therapies are assigned to 1 of 20 treatment subprotocols. EAY191-N4: Patients with RAS pathway mutant ovarian or endometrial cancer are randomized to 1 of 2 arms. ARM I: Patients receive selumetinib orally (PO) twice daily (BID) and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as echocardiogram (ECHO) or multigated acquisition (MUGA), and computed tomography (CT) scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated. ARM II: Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated. EAY191-N2: Patients with inactivating or inferred inactivating NF1 alterations, and hormone receptor positive, HER2-negative metastatic breast cancer. Patients who are fulvestrant naive are assigned to Cohort I, while patients who are fulvestrant resistant are assigned to Cohort II. COHORT I: Patients are randomized to 1 of 2 arms. ARM I:Patients receive fulvestrant intramuscularly (IM) on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, magnetic resonance imaging (MRI), or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study. ARM II: Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study. COHORT II: Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study. EAY191-E4: Patients with solid tumors who previously underwent taxane therapy. Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression. EAY191-A3: Patients with KRAS/NRAS/BRAF mutated low-grade serous ovarian cancer (LGSOC) naive to MEK or CDK4/6 inhibitor therapy are randomized to either combination cohort 1 or monotherapy cohort 1. Patients with LGSOC who have received prior MEK inhibitor therapy are assigned to combination cohort 2. Patients with KRAS/NRAS/HRAS/non-V600E BRAF mutated pancreatic cancer are assigned to combination cohort 3. Patients with all other KRAS/NRAS/HRAS mutated tumor types (excluding LGSOC, non-small cell lung cancer, colorectal cancer, pancreatic, and melanoma) are assigned to combination cohort 4. COMBINATION COHORTS 1, 2, 3, 4: Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up. MONOTHERAPY COHORT 1: Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up. EAY191-S3: Patients with an activating AKT mutation solid tumor. Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up. EAY191-A6: Patients with RAS/RAF/MEK/ERK mutant biliary tract cancers are randomized to 1 of 2 arms. ARM 1: Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo echocardiogram (ECHO) and multigated acquisition scan (MUGA) during screening and on study, a CT with contrast, MRI, or a fludeoxyglucose F-18 positron emission tomography (FDG-PET) during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated. ARM 2: Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated. EAY191-E5: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients who have never received a KRAS G12C inhibitor are randomized to arms A or B. ARM A: Patients receive sotorasib PO once daily (QD) on days 1-28 and panitumumab intravenously IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study. ARM B: Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study. COHORT II: Patients who have received a KRAS G12C inhibitor are assigned to arm C. ARM C: Patients receive combination therapy as in Arm A. EAY191-A2: Patients are assigned to 1 of 3 cohorts. COHORT 1: PARP-inhibitor naive patients are assigned to Arm A. ARM A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. COHORT 2: PARP-inhibitor naive patients are randomized to 1 of 2 arms. ARM B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. ARM C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. COHORT 3: PARP-inhibitor resistant patients are assigned to Arm D. ARM D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression. EAY191-N5: Patients are randomized to 1 of 2 arms. ARM I: Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study. ARM II: Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.