Testing Immunotherapy Before Surgery for Patients with Sarcomatoid Mesothelioma

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05647265

Provider View

This clinical trial is exploring whether giving immunotherapy drugs, nivolumab and ipilimumab, before surgery can help control sarcomatoid mesothelioma, a type of cancer affecting the lining of the lungs. The study aims to see if this approach is more effective than using immunotherapy alone.

Patient Parameters

Program Overview

This phase II study is testing the safety and effectiveness of using immunotherapy drugs, nivolumab and ipilimumab, before surgery in patients with stage I-IIIa sarcomatoid mesothelioma. These drugs are monoclonal antibodies that may help the immune system attack cancer cells and prevent them from growing and spreading. The study aims to find out if this treatment approach is better at controlling the disease compared to using immunotherapy alone.

Description

Primary Objectives:

  • To find out how many patients with potentially removable non-epithelioid mesothelioma can proceed with surgery after receiving nivolumab and ipilimumab.
  • To determine the progression-free survival rate 12 months after starting the treatment.

Secondary Objectives:

  • To assess the rate of complications during or after surgery following the immunotherapy.
  • To evaluate the best response using specific criteria for tumor assessment.
  • To measure the major pathologic response rate and the time to cancer recurrence after surgery.

Exploratory Objectives:

  • To study the relationship between changes in T cell clonality and treatment response.
  • To examine the link between PD-L1 expression and treatment response.
  • To investigate if a new immune signature for mesothelioma can predict treatment response.

Outline:

Patients will receive nivolumab and ipilimumab through an IV and may undergo surgery as part of the study. They will also have CT or MRI scans and PET scans throughout the trial to monitor the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with sarcomatoid or sarcomatoid-dominant biphasic pleural mesothelioma.
  • Cancer stage I-IIIA according to specific medical guidelines.
  • Have measurable or non-measurable disease.
  • No prior treatment that would affect the main study goals.
  • Not pregnant or nursing, and women of childbearing potential must have a negative pregnancy test.
  • Aged 18 years or older.
  • Good overall health with a performance status score of 2 or less.
  • Meet specific blood count and organ function criteria.
  • No active autoimmune diseases, except for certain conditions like vitiligo or type I diabetes.
  • No active infections requiring treatment, including hepatitis B or C.
  • HIV-positive patients can participate if they have an undetectable viral load.
  • No history of heart disease that would interfere with the study.
  • Must have completed at least one cycle of treatment without unresolved side effects that would prevent surgery.
  • No evidence of cancer progression that would prevent surgery.
  • Meet specific lung function criteria for surgery eligibility.

Exclusion Criteria

  • Patients whose cancer cannot be surgically removed or are not good candidates for surgery.
  • Patients with cancer spread to certain areas like the chest wall, abdomen, or other specific regions.
  • Patients with a history of lung disease that causes symptoms.

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