Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
Start Date
11/27/2024
Completion Date
12/15/2026
Summary
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Nivolumab
Ipilimumab
Surgical Procedure
Computed Tomography
Magnetic Resonance Imaging
Positron Emission Tomography
Conditions
Locations
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504
United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508
United States
Katmai Oncology Group
Anchorage, Alaska 99508
United States
Providence Alaska Medical Center
Anchorage, Alaska 99508
United States
Kingman Regional Medical Center
Kingman, Arizona 86401
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
PCR Oncology
Arroyo Grande, California 93420
United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Providence Queen of The Valley
Napa, California 94558
United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405
United States
Beebe Medical Center
Lewes, Delaware 19958
United States
Beebe South Coastal Health Campus
Millville, Delaware 19967
United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware 19713
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971
United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
United States
Rush-Copley Medical Center
Aurora, Illinois 60504
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Rush-Copley Healthcare Center
Yorkville, Illinois 60560
United States
Christiana Care - Union Hospital
Elkton, Maryland 21921
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
United States
Carson Tahoe Regional Medical Center
Carson City, Nevada 89703
United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada 89052
United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
United States
Las Vegas Urology - Green Valley
Henderson, Nevada 89074
United States
Las Vegas Urology - Pebble
Henderson, Nevada 89074
United States
Oncology Las Vegas - Henderson
Henderson, Nevada 89074
United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada 89074
United States
Las Vegas Urology - Pecos
Las Vegas, Nevada 89074
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United States
Hope Cancer Care of Nevada
Las Vegas, Nevada 89103
United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada 89106
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada 89113
United States
Las Vegas Urology - Sunset
Las Vegas, Nevada 89113
United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada 89113
United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
United States
Ann M Wierman MD LTD
Las Vegas, Nevada 89128
United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada 89128
United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada 89128
United States
Oncology Las Vegas - Tenaya
Las Vegas, Nevada 89128
United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada 89128
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada 89148-2405
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
United States
University Cancer Center
Las Vegas, Nevada 89169
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89183
United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada 89048
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Saint Mary's Regional Medical Center
Reno, Nevada 89503
United States
Radiation Oncology Associates
Reno, Nevada 89509
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Duke Cancer Center Southpoint
Durham, North Carolina 27713
United States
Duke Cancer Center Raleigh
Raleigh, North Carolina 27609
United States
Saint Charles Health System
Bend, Oregon 97701
United States
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
United States
Bay Area Hospital
Coos Bay, Oregon 97420
United States
Providence Hood River Memorial Hospital
Hood River, Oregon 97031
United States
Providence Newberg Medical Center
Newberg, Oregon 97132
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United States
Saint Charles Health System-Redmond
Redmond, Oregon 97756
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas 75237
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
United States
Overlake Medical Center
Bellevue, Washington 98004
United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
United States
Providence Regional Cancer System-Centralia
Centralia, Washington 98531
United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
United States
Providence Regional Cancer Partnership
Everett, Washington 98201
United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
United States
Providence Regional Cancer System-Lacey
Lacey, Washington 98503
United States
PeaceHealth Saint John Medical Center
Longview, Washington 98632
United States
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington 98274
United States
Valley Medical Center
Renton, Washington 98055
United States
Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
United States
Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
United States
Swedish Medical Center-First Hill
Seattle, Washington 98122
United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
United States
Providence Regional Cancer System-Shelton
Shelton, Washington 98584
United States
Cancer Care Northwest - Spokane South
Spokane, Washington 99202
United States
Cancer Care Northwest-Valley
Spokane, Washington 99216
United States
Cancer Care Northwest-North Spokane
Spokane, Washington 99218
United States
PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington 98902
United States
Providence Regional Cancer System-Yelm
Yelm, Washington 98597
United States