Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
NCT ID: NCT05647265
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
26 participants
INTERVENTIONAL
2024-11-27
2026-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Nivolumab
Given IV
Ipilimumab
Given IV
Surgical Procedure
Undergo surgery
Computed Tomography
undergo CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Interventions
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Nivolumab
Given IV
Ipilimumab
Given IV
Surgical Procedure
Undergo surgery
Computed Tomography
undergo CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Locations
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
PCR Oncology
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Providence Queen of The Valley
Napa, California, United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Beebe Medical Center
Lewes, Delaware, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, United States
Christiana Care - Union Hospital
Elkton, Maryland, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pebble
Henderson, Nevada, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, United States
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
University Cancer Center
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Saint Mary's Regional Medical Center
Reno, Nevada, United States
Radiation Oncology Associates
Reno, Nevada, United States
Duke University Medical Center
Durham, North Carolina, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Hood River Memorial Hospital
Hood River, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Saint Charles Health System-Redmond
Redmond, Oregon, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
Overlake Medical Center
Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, United States
Valley Medical Center
Renton, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Cancer Care Northwest-Valley
Spokane, Washington, United States
Cancer Care Northwest-North Spokane
Spokane, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
Role: primary
Other Identifiers
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NCI-2022-09320
Identifier Type: OTHER
Identifier Source: secondary_id
A082101
Identifier Type: -
Identifier Source: org_study_id
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