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Immunotherapy before surgery for sarcomatoid mesothelioma

Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

Phase 2 Interventional Alliance for Clinical Trials in Oncology · NCT05647265

This study is testing if giving immunotherapy before surgery can help patients with stage I-IIIa sarcomatoid mesothelioma be able to have surgery and stay cancer-free for longer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment26 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionsnivolumab, ipilimumab, immunotherapy
Locations131 sites (Anchorage, Alaska and 130 other locations)
Trial IDNCT05647265 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the safety and effectiveness of administering immunotherapy with nivolumab and ipilimumab prior to surgery in patients with stage I-IIIa sarcomatoid mesothelioma. The study aims to determine the percentage of patients who can undergo surgery after receiving this neoadjuvant treatment and to assess the progression-free survival rate at 12 months. Secondary objectives include evaluating surgical complications and treatment response rates. Patients will undergo imaging studies throughout the trial to monitor disease progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage I-IIIa sarcomatoid or sarcomatoid-dominant biphasic pleural mesothelioma.

Not a fit: Patients with prior treatments affecting the primary neoplasm or those with non-measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and disease control for patients with sarcomatoid mesothelioma.

How similar studies have performed: Other studies have shown promise with immunotherapy in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Anchorage, Alaska and 130 other locations

+81 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pleural Biphasic MesotheliomaPleural Sarcomatoid Mesothelioma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.