Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

Recruiting now · Phase 2

Conditions studied: Pleural Biphasic Mesothelioma, Pleural Sarcomatoid Mesothelioma

In brief

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.

Key facts

Study ID

NCT05647265

Run by

Alliance for Clinical Trials in Oncology

People needed

26

Starts

2024-11-27

Expected to finish

2026-12-15

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)
• Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States (enrolling)
• Rush-Copley Medical Center — Aurora, Illinois, United States (enrolling)
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
• Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
• Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States (enrolling)
• Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, United States (enrolling)
• Saint Luke's Cancer Institute - Twin Falls — Twin Falls, Idaho, United States (enrolling)
• Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Providence Queen of The Valley — Napa, California, United States (enrolling)
• Providence Medical Foundation - Santa Rosa — Santa Rosa, California, United States (enrolling)
• Providence Santa Rosa Memorial Hospital — Santa Rosa, California, United States (enrolling)
• Kingman Regional Medical Center — Kingman, Arizona, United States (enrolling)
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (enrolling)
• Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
• PCR Oncology — Arroyo Grande, California, United States (enrolling)
• Saint Luke's Cancer Institute - Nampa — Nampa, Idaho, United States (enrolling)
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Carle at The Riverfront — Danville, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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