Taking people in United StatesPhase 2

Testing Immunotherapy Before Surgery for Sarcomatoid Mesothelioma

Tests nivolumab and ipilimumab before surgery in adults with sarcomatoid mesothelioma.

Plain-language title generated from the registry record
Registry title: Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

Key facts

Where: Aberdeen, Anchorage, Arroyo Grande, Aurora, Bellevue, Bellingham, Bend, Boise, Burbank, Carson City, Centralia, Chadds Ford, Chicago, Clackamas, Coos Bay, Dallas, Danville, DeKalb, Durham, Edmonds, Effingham, Elkton, Everett, Fort Worth, Fruitland, Geneva, Glenview, Grayslake, Henderson, Hood River, Issaquah, Jacksonville, Kennewick, Kingman, La Jolla, Lacey, Lake Forest, Las Vegas, Lewes, Longview, Mattoon, Meridian, Millville, Minneapolis, Missoula, Mount Vernon, Nampa, Napa, Newark, Newberg, Oregon City, Orland Park, Pahrump, Phoenix, Portland, Raleigh, Redmond, Rehoboth Beach, Reno, Renton, Richardson, Rochester, Santa Rosa, Scottsdale, Seattle, Sedro-Woolley, Shelton, Spokane, Twin Falls, Urbana, Vancouver, Walla Walla, Warrenville, Wilmington, Yakima, Yelm, and Yorkville, United StatesSee the 132 sites
Phase: Phase 2

Where in United States

Providence Regional Cancer System-AberdeenAberdeen, United StatesTaking people
Alaska Breast Care and Surgery LLCAnchorage, United StatesTaking people
Alaska Oncology and Hematology LLCAnchorage, United StatesTaking people
Alaska Women's Cancer CareAnchorage, United StatesTaking people
Anchorage Associates in Radiation MedicineAnchorage, United StatesTaking people
Katmai Oncology GroupAnchorage, United StatesTaking people
Providence Alaska Medical CenterAnchorage, United StatesTaking people
Anchorage Radiation Therapy CenterAnchorage, United StatesNo longer taking part
PCR OncologyArroyo Grande, United StatesTaking people
Rush-Copley Medical CenterAurora, United StatesTaking people
Overlake Medical CenterBellevue, United StatesNo longer taking part
PeaceHealth Saint Joseph Medical CenterBellingham, United StatesTaking people
Saint Charles Health SystemBend, United StatesTaking people
Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbank, United StatesTaking people
Carson Tahoe Regional Medical CenterCarson City, United StatesTaking people
Providence Regional Cancer System-CentraliaCentralia, United StatesTaking people
Christiana Care Health System-Concord Health CenterChadds Ford, United StatesNo longer taking part
Northwestern UniversityChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
Clackamas Radiation Oncology CenterClackamas, United StatesTaking people
Providence Cancer Institute Clackamas ClinicClackamas, United StatesNo longer taking part
Bay Area HospitalCoos Bay, United StatesTaking people
UT Southwestern Simmons Cancer Center - RedBirdDallas, United StatesTaking people
UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
Carle at The RiverfrontDanville, United StatesTaking people
Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesTaking people
Duke Cancer Center SouthpointDurham, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
Swedish Cancer Institute-EdmondsEdmonds, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Christiana Care - Union HospitalElkton, United StatesNo longer taking part
Providence Regional Cancer PartnershipEverett, United StatesTaking people
UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, United StatesTaking people
Saint Luke's Cancer Institute - FruitlandFruitland, United StatesTaking people
Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
Northwestern Medicine Glenview Outpatient CenterGlenview, United StatesTaking people
Northwestern Medicine Grayslake Outpatient CenterGrayslake, United StatesTaking people
Comprehensive Cancer Centers of Nevada - HendersonHenderson, United StatesTaking people
Comprehensive Cancer Centers of Nevada-Horizon RidgeHenderson, United StatesTaking people
Comprehensive Cancer Centers of Nevada-Southeast HendersonHenderson, United StatesTaking people
Oncology Las Vegas - HendersonHenderson, United StatesTaking people
Urology Specialists of Nevada - Green ValleyHenderson, United StatesTaking people
Cancer and Blood Specialists-HendersonHenderson, United StatesNo longer taking part
Las Vegas Cancer Center-HendersonHenderson, United StatesNo longer taking part
Las Vegas Urology - Green ValleyHenderson, United StatesNo longer taking part
Las Vegas Urology - PebbleHenderson, United StatesNo longer taking part
Providence Hood River Memorial HospitalHood River, United StatesTaking people
Swedish Cancer Institute-IssaquahIssaquah, United StatesTaking people
Mayo Clinic in FloridaJacksonville, United StatesTaking people
Kadlec Clinic Hematology and OncologyKennewick, United StatesTaking people
Kingman Regional Medical CenterKingman, United StatesTaking people
UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
Providence Regional Cancer System-LaceyLacey, United StatesTaking people
Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesTaking people
Comprehensive Cancer Centers of NevadaLas Vegas, United StatesTaking people
Comprehensive Cancer Centers of Nevada - Central ValleyLas Vegas, United StatesTaking people
Comprehensive Cancer Centers of Nevada - NorthwestLas Vegas, United StatesTaking people
Comprehensive Cancer Centers of Nevada - Town CenterLas Vegas, United StatesTaking people
Comprehensive Cancer Centers of Nevada-SummerlinLas Vegas, United StatesTaking people
Hope Cancer Care of NevadaLas Vegas, United StatesTaking people
Oncology Las Vegas - TenayaLas Vegas, United StatesTaking people
OptumCare Cancer Care at CharlestonLas Vegas, United StatesTaking people
OptumCare Cancer Care at Fort ApacheLas Vegas, United StatesTaking people
OptumCare Cancer Care at MountainViewLas Vegas, United StatesTaking people
Radiation Oncology Centers of Nevada CentralLas Vegas, United StatesTaking people
Radiation Oncology Centers of Nevada SoutheastLas Vegas, United StatesTaking people
Summerlin Hospital Medical CenterLas Vegas, United StatesTaking people
Sunrise Hospital and Medical CenterLas Vegas, United StatesTaking people
University Medical Center of Southern NevadaLas Vegas, United StatesTaking people
Urology Specialists of Nevada - CentralLas Vegas, United StatesTaking people
Urology Specialists of Nevada - NorthwestLas Vegas, United StatesTaking people
Urology Specialists of Nevada - SouthwestLas Vegas, United StatesTaking people
Ann M Wierman MD LTDLas Vegas, United StatesNo longer taking part
Las Vegas Cancer Center-Medical CenterLas Vegas, United StatesNo longer taking part
Las Vegas Prostate Cancer CenterLas Vegas, United StatesNo longer taking part
Las Vegas Urology - Cathedral RockLas Vegas, United StatesNo longer taking part
Las Vegas Urology - PecosLas Vegas, United StatesNo longer taking part
Las Vegas Urology - Smoke RanchLas Vegas, United StatesNo longer taking part
Las Vegas Urology - SunsetLas Vegas, United StatesNo longer taking part
University Cancer CenterLas Vegas, United StatesNo longer taking part
Beebe Medical CenterLewes, United StatesNo longer taking part
PeaceHealth Saint John Medical CenterLongview, United StatesTaking people
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
Saint Luke's Cancer Institute - MeridianMeridian, United StatesTaking people
Beebe South Coastal Health CampusMillville, United StatesNo longer taking part
University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesTaking people
Saint Patrick Hospital - Community HospitalMissoula, United StatesTaking people
Skagit Regional Health Cancer Care CenterMount Vernon, United StatesTaking people
Saint Luke's Cancer Institute - NampaNampa, United StatesTaking people
Providence Queen of The ValleyNapa, United StatesTaking people
Christiana Care Health System-Christiana HospitalNewark, United StatesNo longer taking part
Delaware Clinical and Laboratory Physicians PANewark, United StatesNo longer taking part
Helen F Graham Cancer CenterNewark, United StatesNo longer taking part
Medical Oncology Hematology Consultants PANewark, United StatesNo longer taking part
Providence Newberg Medical CenterNewberg, United StatesTaking people
Providence Willamette Falls Medical CenterOregon City, United StatesTaking people
Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
Hope Cancer Care of Nevada-PahrumpPahrump, United StatesTaking people
Mayo Clinic Hospital in ArizonaPhoenix, United StatesTaking people
Providence Portland Medical CenterPortland, United StatesTaking people
Providence Saint Vincent Medical CenterPortland, United StatesTaking people
Duke Cancer Center RaleighRaleigh, United StatesTaking people
Saint Charles Health System-RedmondRedmond, United StatesTaking people
Beebe Health CampusRehoboth Beach, United StatesNo longer taking part
Renown Regional Medical CenterReno, United StatesTaking people
Saint Mary's Regional Medical CenterReno, United StatesTaking people
Radiation Oncology AssociatesReno, United StatesNo longer taking part
Valley Medical CenterRenton, United StatesTaking people
UT Southwestern Clinical Center at Richardson/PlanoRichardson, United StatesTaking people
Mayo Clinic in RochesterRochester, United StatesTaking people
Providence Medical Foundation - Santa RosaSanta Rosa, United StatesTaking people
Providence Santa Rosa Memorial HospitalSanta Rosa, United StatesTaking people
Mayo Clinic in ArizonaScottsdale, United StatesTaking people
Swedish Medical Center-Ballard CampusSeattle, United StatesTaking people
Swedish Medical Center-Cherry HillSeattle, United StatesTaking people
Swedish Medical Center-First HillSeattle, United StatesTaking people
PeaceHealth United General Medical CenterSedro-Woolley, United StatesTaking people
Providence Regional Cancer System-SheltonShelton, United StatesNo longer taking part
Cancer Care Northwest - Spokane SouthSpokane, United StatesTaking people
Cancer Care Northwest-North SpokaneSpokane, United StatesTaking people
Cancer Care Northwest-ValleySpokane, United StatesTaking people
Saint Luke's Cancer Institute - Twin FallsTwin Falls, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
PeaceHealth Southwest Medical CenterVancouver, United StatesTaking people
Providence Saint Mary Regional Cancer CenterWalla Walla, United StatesTaking people
Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesTaking people
Christiana Care Health System-Wilmington HospitalWilmington, United StatesNo longer taking part
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, United StatesTaking people
Providence Regional Cancer System-YelmYelm, United StatesNo longer taking part
Rush-Copley Healthcare CenterYorkville, United StatesTaking people

Questions to ask the study team

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Trial details

Who runs it: Alliance for Clinical Trials in Oncology
Trial code: NCT05647265
Record updated: 5 August 2026
Original description: 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.Read full original descriptionShow less
Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma
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.
Inclusion: 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: No patients deemed to be unresectable or poor surgical candidates; No patients with a history of symptomatic interstitial lung disease; 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.
ClinicalTrials.gov NCT05647265