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Purpose

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma - Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition - Measurable disease or non-measurable disease as defined - No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint - No treatment with hormones or other chemotherapeutic agents except for hormones administered for non-disease-related conditions (e.g., insulin for diabetes and or hormonal therapy for breast, prostate cancer etc.) - Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky >= 60% - Absolute neutrophil count (ANC) >= 1,000/mm^3 - Leukocytes >= 2,000/mm^3 - Platelet count >= 100,000/mm^3 - Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 40 mL/min - Total bilirubin =<1.5 x ULN, except patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dl - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN - Alkaline (alk) phosphatase (phos) =< 3.0 x ULN - No active, known or suspected autoimmune disease except for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger - No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody - No history of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFalpha) therapies or other immunosuppressant medications during the study - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery - STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection - STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =< 2 or Karnofsky >= 60% - STEP 2 ELIGIBILITY CRITERIA: Predicted forced expiratory volume in 1 second (FEV1) > 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) > 35% - STEP 2 ELIGIBILITY CRITERIA: Registration to step 2 no less than 21 days and no more than 90 days after the last dose of neoadjuvant therapy

Exclusion Criteria

  • No patients deemed to be unresectable or poor surgical candidates - No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes - No patients with a history of symptomatic interstitial lung disease

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment (nivolumab, ipilimumab, surgery) 		Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.
  • Biological: Nivolumab
    Given IV
    Other names:
    • 946414-94-4, BMS-936558, CMAB819, MDX-1106, NIVO, NIVOLUMAB, Nivolumab, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo
  • Biological: Ipilimumab
    Given IV
    Other names:
    • 477202-00-9, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, IPILIMUMAB, ipilimumab, Ipilimumab Biosimilar CS1002, MDX-010, MDX-010, MDX-CTLA4, Yervoy
  • Procedure: Surgical Procedure
    Undergo surgery
  • Procedure: Computed Tomography
    undergo CT
    Other names:
    • CAT, CAT Scan,
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • MRI
  • Procedure: Positron Emission Tomography
    Undergo PET
    Other names:
    • Medical Imaging, PET, Pet Scan

Recruiting Locations

Anchorage Associates in Radiation Medicine
Anchorage 5879400, Alaska 5879092 98508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Breast Care and Surgery LLC
Anchorage 5879400, Alaska 5879092 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Anchorage 5879400, Alaska 5879092 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Anchorage 5879400, Alaska 5879092 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Anchorage 5879400, Alaska 5879092 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Anchorage 5879400, Alaska 5879092 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Kingman Regional Medical Center
Kingman 5301067, Arizona 5551752 86401
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Mayo Clinic Hospital in Arizona
Phoenix 5308655, Arizona 5551752 85054
Contact:
Site Public Contact
855-776-0015

Mayo Clinic in Arizona
Scottsdale 5313457, Arizona 5551752 85259
Contact:
Site Public Contact
855-776-0015

PCR Oncology
Arroyo Grande 5324802, California 5332921 93420
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank 5331835, California 5332921 91505
Contact:
Site Public Contact
818-847-4793
Najee.Boucher@providence.org

Providence Queen of The Valley
Napa 5376095, California 5332921 94558
Contact:
Site Public Contact
707-521-3830

Providence Medical Foundation - Santa Rosa
Santa Rosa 5393287, California 5332921 95403
Contact:
Site Public Contact
707-521-3830

Providence Santa Rosa Memorial Hospital
Santa Rosa 5393287, California 5332921 95405
Contact:
Site Public Contact
707-521-3830

Beebe Medical Center
Lewes 4143354, Delaware 4142224 19958
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

Beebe South Coastal Health Campus
Millville 4143696, Delaware 4142224 19967
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

Helen F Graham Cancer Center
Newark 4143861, Delaware 4142224 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark 4143861, Delaware 4142224 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Christiana Care Health System-Christiana Hospital
Newark 4143861, Delaware 4142224 19718
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Beebe Health Campus
Rehoboth Beach 4144284, Delaware 4142224 19971
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

Christiana Care Health System-Wilmington Hospital
Wilmington 4145381, Delaware 4142224 19801
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224-9980
Contact:
Site Public Contact
855-776-0015

Saint Luke's Cancer Institute - Boise
Boise 5586437, Idaho 5596512 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Fruitland
Fruitland 5593708, Idaho 5596512 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian 5600685, Idaho 5596512 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Nampa
Nampa 5601933, Idaho 5596512 83687
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls 5610810, Idaho 5596512 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Rush - Copley Medical Center
Aurora 4883817, Illinois 4896861 60504
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Carle at The Riverfront
Danville 4889426, Illinois 4896861 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb 4889553, Illinois 4896861 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Effingham
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Delnor
Geneva 4893591, Illinois 4896861 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Northwestern Medicine Glenview Outpatient Center
Glenview 4893886, Illinois 4896861 60026
Contact:
Site Public Contact
312-695-1102

Northwestern Medicine Grayslake Outpatient Center
Grayslake 4894465, Illinois 4896861 60030
Contact:
Site Public Contact
312-695-1102

Northwestern Medicine Lake Forest Hospital
Lake Forest 4899012, Illinois 4896861 60045
Contact:
Site Public Contact
cancertrials@northwestern.edu

Carle Physician Group-Mattoon/Charleston
Mattoon 4244099, Illinois 4896861 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Orland Park
Orland Park 4904937, Illinois 4896861 60462
Contact:
Site Public Contact
nctnprogram_rhlccc@northwestern.edu

Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville 4915525, Illinois 4896861 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Rush-Copley Healthcare Center
Yorkville 4917298, Illinois 4896861 60560
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Christiana Care - Union Hospital
Elkton 4354234, Maryland 4361885 21921
Contact:
Site Public Contact
410-443-1360
frank.crum@christianacare.org

Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Site Public Contact
855-776-0015

Saint Patrick Hospital - Community Hospital
Missoula 5666639, Montana 5667009 59802
Contact:
Site Public Contact
406-327-3118
amy.hanneman@providence.org

Carson Tahoe Regional Medical Center
Carson City 5501344, Nevada 5509151 89703
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Cancer and Blood Specialists-Henderson
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson 5505411, Nevada 5509151 89074
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

GenesisCare USA - Henderson
Henderson 5505411, Nevada 5509151 89074
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Las Vegas Urology - Green Valley
Henderson 5505411, Nevada 5509151 89074
Contact:
Site Public Contact
research@sncrf.org

Las Vegas Urology - Pebble
Henderson 5505411, Nevada 5509151 89074
Contact:
Site Public Contact
research@sncrf.org

Urology Specialists of Nevada - Green Valley
Henderson 5505411, Nevada 5509151 89074
Contact:
Site Public Contact
research@sncrf.org

Las Vegas Urology - Pecos
Las Vegas 5506956, Nevada 5509151 89074
Contact:
Site Public Contact
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

University Medical Center of Southern Nevada
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada
Las Vegas 5506956, Nevada 5509151 89103
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central
Las Vegas 5506956, Nevada 5509151 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Urology Specialists of Nevada - Central
Las Vegas 5506956, Nevada 5509151 89106
Contact:
Site Public Contact
research@sncrf.org

GenesisCare USA - Las Vegas
Las Vegas 5506956, Nevada 5509151 89109
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Sunrise Hospital and Medical Center
Las Vegas 5506956, Nevada 5509151 89109
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Las Vegas Prostate Cancer Center
Las Vegas 5506956, Nevada 5509151 89113
Contact:
Site Public Contact
research@sncrf.org

Las Vegas Urology - Sunset
Las Vegas 5506956, Nevada 5509151 89113
Contact:
Site Public Contact
research@sncrf.org

Urology Specialists of Nevada - Southwest
Las Vegas 5506956, Nevada 5509151 89113
Contact:
Site Public Contact
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Las Vegas 5506956, Nevada 5509151 89119
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Ann M Wierman MD LTD
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

GenesisCare USA - Vegas Tenaya
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Las Vegas Urology - Cathedral Rock
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
research@sncrf.org

Las Vegas Urology - Smoke Ranch
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
research@smcrf.org

OptumCare Cancer Care at MountainView
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Urology Specialists of Nevada - Northwest
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas 5506956, Nevada 5509151 89135
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Summerlin Hospital Medical Center
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

GenesisCare USA - Fort Apache
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas 5506956, Nevada 5509151 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

University Cancer Center
Las Vegas 5506956, Nevada 5509151 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada-Pahrump
Pahrump 5509851, Nevada 5509151 89048
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Renown Regional Medical Center
Reno 5511077, Nevada 5509151 89502
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Saint Mary's Regional Medical Center
Reno 5511077, Nevada 5509151 89503
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Associates
Reno 5511077, Nevada 5509151 89509
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Contact:
Site Public Contact
888-275-3853

Saint Charles Health System
Bend 5713587, Oregon 5744337 97701
Contact:
Site Public Contact
541-706-2909
nosall@stcharleshealthcare.org

Clackamas Radiation Oncology Center
Clackamas 5719308, Oregon 5744337 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Bay Area Hospital
Coos Bay 5720495, Oregon 5744337 97420
Contact:
Site Public Contact
541-269-8392
cherie.cox@bayareahospital.org

Providence Newberg Medical Center
Newberg 5742726, Oregon 5744337 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Willamette Falls Medical Center
Oregon City 5744253, Oregon 5744337 97045
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Saint Charles Health System-Redmond
Redmond 5747882, Oregon 5744337 97756
Contact:
Site Public Contact
541-706-2909

Christiana Care Health System-Concord Health Center
Chadds Ford 4557084, Pennsylvania 6254927 19317
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Providence Regional Cancer System-Aberdeen
Aberdeen 5785243, Washington 5815135 98520
Contact:
Site Public Contact
360-412-8958
deidre.dillon@providence.org

PeaceHealth Saint Joseph Medical Center
Bellingham 5786899, Washington 5815135 98225
Contact:
Site Public Contact
360-788-8223

Providence Regional Cancer System-Centralia
Centralia 5789683, Washington 5815135 98531
Contact:
Site Public Contact
360-412-8958
deidre.dillon@providence.org

Swedish Cancer Institute-Edmonds
Edmonds 5793427, Washington 5815135 98026
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

Providence Regional Cancer Partnership
Everett 5793933, Washington 5815135 98201
Contact:
Site Public Contact
425-261-3529
marilyn.birchman@providence.org

Swedish Cancer Institute-Issaquah
Issaquah 5798487, Washington 5815135 98029
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

Kadlec Clinic Hematology and Oncology
Kennewick 5799610, Washington 5815135 99336
Contact:
Site Public Contact
509-783-4637
research@kadlecmed.org

Providence Regional Cancer System-Lacey
Lacey 5800112, Washington 5815135 98503
Contact:
Site Public Contact
360-412-8958
deidre.dillon@providence.org

PeaceHealth Saint John Medical Center
Longview 5801617, Washington 5815135 98632
Contact:
Site Public Contact
360-514-2016
kmakin-bond@peacehealth.org

Skagit Regional Health Cancer Care Center
Mount Vernon 5804127, Washington 5815135 98274
Contact:
Site Public Contact
360-814-2182
rcccclinicalresearch@skagitvalleyhospital.org

Valley Medical Center
Renton 5808189, Washington 5815135 98055
Contact:
Site Public Contact
425-228-3440
research@valleymed.org

Swedish Medical Center-Ballard Campus
Seattle 5809844, Washington 5815135 98107
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

Swedish Medical Center-Cherry Hill
Seattle 5809844, Washington 5815135 98122-5711
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

Swedish Medical Center-First Hill
Seattle 5809844, Washington 5815135 98122
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

PeaceHealth United General Medical Center
Sedro-Woolley 5809902, Washington 5815135 98284
Contact:
Site Public Contact
360-788-8223
rcrompton@peacehealth.org

PeaceHealth Southwest Medical Center
Vancouver 5814616, Washington 5815135 98664
Contact:
Site Public Contact
360-514-3940
kmakin-bond@peacehealth.org

Providence Saint Mary Regional Cancer Center
Walla Walla 5814916, Washington 5815135 99362
Contact:
Site Public Contact
509-897-5993
Cheryl.Dodd@providence.org

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima 5816605, Washington 5815135 98902
Contact:
Site Public Contact
509-574-3535
Memorial-ClinicalTrials@yvmh.org

More Details

NCT ID
NCT05647265
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

Aaron Mansfield, MD
507-293-0569
mansfield.aaron@mayo.edu

Detailed Description

PRIMARY OBJECTIVES: I. To determine the percentage of patients with potentially resectable non-epithelioid mesothelioma who are able to proceed with surgery after neoadjuvant ipilimumab and nivolumab. II. To determine the progression-free survival rate at 12 months after the initiation of neoadjuvant ipilimumab and nivolumab. SECONDARY OBJECTIVES: I. To determine the rate of intra-operative or post-operative complications following neoadjuvant immunotherapy. II. Best response per modified pleural Response Evaluation Criteria in Solid Tumors (RECIST). III. Major pathologic response rate. IV. Time to recurrence after surgery. EXPLORATORY OBJECTIVES: I. To evaluate the association between the change in peripheral T cell clonality relative to baseline and treatment response. II. To evaluate the association between PD-L1 expression at baseline and treatment response. III. To evaluate whether a novel mesothelioma immune signature identified by Dr. Mansfield's laboratory is predictive of response. OUTLINE: Patients receive nivolumab intravenously (IV), ipilimumab IV, and may undergo surgery on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and positron emission tomography (PET) throughout the trial.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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