Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
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
- Pleural Biphasic Mesothelioma
- Pleural Sarcomatoid Mesothelioma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Anchorage, Alaska 98508
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Women's Cancer Care
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Katmai Oncology Group
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Providence Alaska Medical Center
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Kingman Regional Medical Center
Kingman, Arizona 86401
Kingman, Arizona 86401
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
PCR Oncology
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Burbank, California 91505
Providence Queen of The Valley
Napa, California 94558
Napa, California 94558
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
Santa Rosa, California 95403
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405
Santa Rosa, California 95405
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Beebe Medical Center
Lewes, Delaware 19958
Lewes, Delaware 19958
Beebe South Coastal Health Campus
Millville, Delaware 19967
Millville, Delaware 19967
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
Newark, Delaware 19718
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
Wilmington, Delaware 19801
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Rush - Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
Grayslake, Illinois 60030
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Lake Forest, Illinois 60045
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Yorkville, Illinois 60560
Christiana Care - Union Hospital
Elkton, Maryland 21921
Elkton, Maryland 21921
Mayo Clinic in Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Missoula, Montana 59802
Carson Tahoe Regional Medical Center
Carson City, Nevada 89703
Carson City, Nevada 89703
Cancer and Blood Specialists-Henderson
Henderson, Nevada 89052
Henderson, Nevada 89052
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Henderson, Nevada 89052
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada 89052
Henderson, Nevada 89052
OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Henderson, Nevada 89052
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
Henderson, Nevada 89074
GenesisCare USA - Henderson
Henderson, Nevada 89074
Henderson, Nevada 89074
Las Vegas Urology - Green Valley
Henderson, Nevada 89074
Henderson, Nevada 89074
Urology Specialists of Nevada - Green Valley
Henderson, Nevada 89074
Henderson, Nevada 89074
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Hope Cancer Care of Nevada
Las Vegas, Nevada 89103
Las Vegas, Nevada 89103
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Urology Specialists of Nevada - Central
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
GenesisCare USA - Las Vegas
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Las Vegas Prostate Cancer Center
Las Vegas, Nevada 89113
Las Vegas, Nevada 89113
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada 89113
Las Vegas, Nevada 89113
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
Las Vegas, Nevada 89119
Ann M Wierman MD LTD
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
Las Vegas, Nevada 89135
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
GenesisCare USA - Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
University Cancer Center
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada 89048
Pahrump, Nevada 89048
Renown Regional Medical Center
Reno, Nevada 89502
Reno, Nevada 89502
Saint Mary's Regional Medical Center
Reno, Nevada 89503
Reno, Nevada 89503
Radiation Oncology Associates
Reno, Nevada 89509
Reno, Nevada 89509
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
Saint Charles Health System
Bend, Oregon 97701
Bend, Oregon 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Bay Area Hospital
Coos Bay, Oregon 97420
Coos Bay, Oregon 97420
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Oregon City, Oregon 97045
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Saint Charles Health System-Redmond
Redmond, Oregon 97756
Redmond, Oregon 97756
Contact:
Site Public Contact
541-706-2909
Site Public Contact
541-706-2909
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Chadds Ford, Pennsylvania 19317
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
Aberdeen, Washington 98520
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Bellingham, Washington 98225
Contact:
Site Public Contact
360-788-8223
Site Public Contact
360-788-8223
Providence Regional Cancer System-Centralia
Centralia, Washington 98531
Centralia, Washington 98531
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Edmonds, Washington 98026
Providence Regional Cancer Partnership
Everett, Washington 98201
Everett, Washington 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Issaquah, Washington 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
Kennewick, Washington 99336
Providence Regional Cancer System-Lacey
Lacey, Washington 98503
Lacey, Washington 98503
PeaceHealth Saint John Medical Center
Longview, Washington 98632
Longview, Washington 98632
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington 98274
Mount Vernon, Washington 98274
Valley Medical Center
Renton, Washington 98055
Renton, Washington 98055
Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
Seattle, Washington 98107
Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
Seattle, Washington 98122-5711
Swedish Medical Center-First Hill
Seattle, Washington 98122
Seattle, Washington 98122
PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
Sedro-Woolley, Washington 98284
PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Vancouver, Washington 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
Walla Walla, Washington 99362
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington 98902
Yakima, Washington 98902
More Details
- NCT ID
- NCT05647265
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
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.