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Immunotherapy Before Surgery for Sarcomatoid Mesothelioma

This study is testing if giving two immunotherapy drugs, nivolumab and ipilimumab, before surgery is a safe and effective way to treat sarcomatoid mesothelioma. These drugs work by helping your body's immune system fight cancer cells. Researchers believe that giving these drugs before surgery might control the disease better than surgery alone. The study will enroll about 26 patients with stage I-IIIA sarcomatoid or biphasic pleural mesothelioma. Success will be measured by how many patients can have surgery after immunotherapy and how long they live without the cancer growing (progression-free survival) at 12 months. This study is currently recruiting patients.

Study design
This is a Phase II interventional study, meaning all participants receive the study treatment. It plans to enroll 26 participants.
What's involved
You would receive nivolumab and ipilimumab intravenously (through a vein), potentially undergo surgery, and have CT or MRI scans and PET scans throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured at 12 months after starting the immunotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05647265

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Alliance for Clinical Trials in Oncology
~26 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:NivolumabIpilimumabSurgical ProcedureComputed TomographyMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
104 of 132 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Surgery Rate
Measured over immediately after the completion of neoadjuvant immunotherapy and surgery
+1 more outcome measured

Conditions

Pleural Biphasic Mesothelioma
Pleural Sarcomatoid Mesothelioma

Explore related trials

Pleural Malignant Mesothelioma

Where it's being run

132 sites across 16 states
Nevada41
Washington24
Illinois15
Oregon10
Delaware8
Alaska7
California6
Idaho5

Who to contact

Aaron Mansfield, MD
[email protected]
507-293-0569
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

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
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 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

What this trial measures

  • Surgery Rateimmediately after the completion of neoadjuvant immunotherapy and surgery

    The rate of surgery after neoadjuvant immunotherapy among the feasibility analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.

  • Progression free survival (PFS)At 12 months after initiation of neoadjuvant immunotherapy

    PFS will be determined per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The rate of PFS at 12 months after the initiation of neoadjuvant immunotherapy among the feasibility and efficacy analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.