NCT05647265RecruitingPhase 2
Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 29 Nov 2022
- Start date
- 27 Nov 2024
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Diseases
- Mesothelioma
- NCT number
- NCT05647265
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 26
- From 27 Nov 2024 to the primary completion date, 15 Dec 2026
- 132 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No patients deemed to be unresectable or poor surgical candidates
Other illness
- No patients with a history of symptomatic interstitial lung disease
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (132)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence Regional Cancer System-Aberdeen Coordinator of this site? Confirm its status | Aberdeen | United States | Recruiting |
| Alaska Women's Cancer Care Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Katmai Oncology Group Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Alaska Oncology and Hematology LLC Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Anchorage Associates in Radiation Medicine Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Anchorage Radiation Therapy Center Coordinator of this site? Confirm its status | Anchorage | United States | Suspended |
| Providence Alaska Medical Center Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Alaska Breast Care and Surgery LLC Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| PCR Oncology Coordinator of this site? Confirm its status | Arroyo Grande | United States | Recruiting |
| Rush-Copley Medical Center Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Overlake Medical Center Coordinator of this site? Confirm its status | Bellevue | United States | Suspended |
| PeaceHealth Saint Joseph Medical Center Coordinator of this site? Confirm its status | Bellingham | United States | Recruiting |
| Saint Charles Health System Coordinator of this site? Confirm its status | Bend | United States | Recruiting |
| Saint Luke's Cancer Institute - Boise Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Coordinator of this site? Confirm its status | Burbank | United States | Recruiting |
| Carson Tahoe Regional Medical Center Coordinator of this site? Confirm its status | Carson City | United States | Recruiting |
| Providence Regional Cancer System-Centralia Coordinator of this site? Confirm its status | Centralia | United States | Recruiting |
| Christiana Care Health System-Concord Health Center Coordinator of this site? Confirm its status | Chadds Ford | United States | Active, not recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Clackamas Radiation Oncology Center Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| Providence Cancer Institute Clackamas Clinic Coordinator of this site? Confirm its status | Clackamas | United States | Suspended |
| Bay Area Hospital Coordinator of this site? Confirm its status | Coos Bay | United States | Recruiting |
| UT Southwestern Simmons Cancer Center - RedBird Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Northwestern Medicine Cancer Center Kishwaukee Coordinator of this site? Confirm its status | DeKalb | United States | Recruiting |
| Duke Cancer Center Southpoint Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Swedish Cancer Institute-Edmonds Coordinator of this site? Confirm its status | Edmonds | United States | Recruiting |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Recruiting |
| Christiana Care - Union Hospital Coordinator of this site? Confirm its status | Elkton | United States | Active, not recruiting |
| Providence Regional Cancer Partnership Coordinator of this site? Confirm its status | Everett | United States | Recruiting |
| UT Southwestern/Simmons Cancer Center-Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Saint Luke's Cancer Institute - Fruitland Coordinator of this site? Confirm its status | Fruitland | United States | Recruiting |
| Northwestern Medicine Cancer Center Delnor Coordinator of this site? Confirm its status | Geneva | United States | Recruiting |
| Northwestern Medicine Glenview Outpatient Center Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Northwestern Medicine Grayslake Outpatient Center Coordinator of this site? Confirm its status | Grayslake | United States | Recruiting |
| Oncology Las Vegas - Henderson Coordinator of this site? Confirm its status | Henderson | United States | Recruiting |
| Las Vegas Cancer Center-Henderson Coordinator of this site? Confirm its status | Henderson | United States | Suspended |
| Las Vegas Urology - Pebble Coordinator of this site? Confirm its status | Henderson | United States | Suspended |
| Urology Specialists of Nevada - Green Valley Coordinator of this site? Confirm its status | Henderson | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Coordinator of this site? Confirm its status | Henderson | United States | Recruiting |
| Las Vegas Urology - Green Valley Coordinator of this site? Confirm its status | Henderson | United States | Suspended |
| Cancer and Blood Specialists-Henderson Coordinator of this site? Confirm its status | Henderson | United States | Suspended |
| Comprehensive Cancer Centers of Nevada - Henderson Coordinator of this site? Confirm its status | Henderson | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Coordinator of this site? Confirm its status | Henderson | United States | Recruiting |
| Providence Hood River Memorial Hospital Coordinator of this site? Confirm its status | Hood River | United States | Recruiting |
| Swedish Cancer Institute-Issaquah Coordinator of this site? Confirm its status | Issaquah | United States | Recruiting |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Kadlec Clinic Hematology and Oncology Coordinator of this site? Confirm its status | Kennewick | United States | Recruiting |
| Kingman Regional Medical Center Coordinator of this site? Confirm its status | Kingman | United States | Recruiting |
| Providence Regional Cancer System-Lacey Coordinator of this site? Confirm its status | Lacey | United States | Recruiting |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Northwestern Medicine Lake Forest Hospital Coordinator of this site? Confirm its status | Lake Forest | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada - Northwest Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Hope Cancer Care of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada-Summerlin Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Radiation Oncology Centers of Nevada Central Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada - Central Valley Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Las Vegas Urology - Cathedral Rock Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| OptumCare Cancer Care at Charleston Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| OptumCare Cancer Care at Fort Apache Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Sunrise Hospital and Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Urology Specialists of Nevada - Southwest Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Oncology Las Vegas - Tenaya Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Urology Specialists of Nevada - Central Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Radiation Oncology Centers of Nevada Southeast Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Summerlin Hospital Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Las Vegas Urology - Smoke Ranch Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| Las Vegas Urology - Sunset Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| Urology Specialists of Nevada - Northwest Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Las Vegas Prostate Cancer Center Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| University Cancer Center Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| OptumCare Cancer Care at MountainView Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada - Town Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Las Vegas Urology - Pecos Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| Las Vegas Cancer Center-Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| Ann M Wierman MD LTD Coordinator of this site? Confirm its status | Las Vegas | United States | Suspended |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Beebe Medical Center Coordinator of this site? Confirm its status | Lewes | United States | Active, not recruiting |
| PeaceHealth Saint John Medical Center Coordinator of this site? Confirm its status | Longview | United States | Recruiting |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Recruiting |
| Saint Luke's Cancer Institute - Meridian Coordinator of this site? Confirm its status | Meridian | United States | Recruiting |
| Beebe South Coastal Health Campus Coordinator of this site? Confirm its status | Millville | United States | Active, not recruiting |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Saint Patrick Hospital - Community Hospital Coordinator of this site? Confirm its status | Missoula | United States | Recruiting |
| Skagit Regional Health Cancer Care Center Coordinator of this site? Confirm its status | Mount Vernon | United States | Recruiting |
| Saint Luke's Cancer Institute - Nampa Coordinator of this site? Confirm its status | Nampa | United States | Recruiting |
| Providence Queen of The Valley Coordinator of this site? Confirm its status | Napa | United States | Recruiting |
| Delaware Clinical and Laboratory Physicians PA Coordinator of this site? Confirm its status | Newark | United States | Active, not recruiting |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Active, not recruiting |
| Christiana Care Health System-Christiana Hospital Coordinator of this site? Confirm its status | Newark | United States | Active, not recruiting |
| Medical Oncology Hematology Consultants PA Coordinator of this site? Confirm its status | Newark | United States | Active, not recruiting |
| Providence Newberg Medical Center Coordinator of this site? Confirm its status | Newberg | United States | Recruiting |
| Providence Willamette Falls Medical Center Coordinator of this site? Confirm its status | Oregon City | United States | Recruiting |
| Northwestern Medicine Orland Park Coordinator of this site? Confirm its status | Orland Park | United States | Recruiting |
| Hope Cancer Care of Nevada-Pahrump Coordinator of this site? Confirm its status | Pahrump | United States | Recruiting |
| Mayo Clinic Hospital in Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Duke Cancer Center Raleigh Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Saint Charles Health System-Redmond Coordinator of this site? Confirm its status | Redmond | United States | Recruiting |
| Beebe Health Campus Coordinator of this site? Confirm its status | Rehoboth Beach | United States | Active, not recruiting |
| Saint Mary's Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Radiation Oncology Associates Coordinator of this site? Confirm its status | Reno | United States | Suspended |
| Valley Medical Center Coordinator of this site? Confirm its status | Renton | United States | Recruiting |
| UT Southwestern Clinical Center at Richardson/Plano Coordinator of this site? Confirm its status | Richardson | United States | Recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Providence Medical Foundation - Santa Rosa Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Providence Santa Rosa Memorial Hospital Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Swedish Medical Center-Ballard Campus Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Swedish Medical Center-Cherry Hill Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Swedish Medical Center-First Hill Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| PeaceHealth United General Medical Center Coordinator of this site? Confirm its status | Sedro-Woolley | United States | Recruiting |
| Providence Regional Cancer System-Shelton Coordinator of this site? Confirm its status | Shelton | United States | Suspended |
| Cancer Care Northwest - Spokane South Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Cancer Care Northwest-Valley Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Cancer Care Northwest-North Spokane Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Saint Luke's Cancer Institute - Twin Falls Coordinator of this site? Confirm its status | Twin Falls | United States | Recruiting |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| PeaceHealth Southwest Medical Center Coordinator of this site? Confirm its status | Vancouver | United States | Recruiting |
| Providence Saint Mary Regional Cancer Center Coordinator of this site? Confirm its status | Walla Walla | United States | Recruiting |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Recruiting |
| Christiana Care Health System-Wilmington Hospital Coordinator of this site? Confirm its status | Wilmington | United States | Active, not recruiting |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Coordinator of this site? Confirm its status | Yakima | United States | Recruiting |
| Providence Regional Cancer System-Yelm Coordinator of this site? Confirm its status | Yelm | United States | Suspended |
| Rush-Copley Healthcare Center Coordinator of this site? Confirm its status | Yorkville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.