NCT05647265

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

Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the percentage of patients with potentially resectable non-epithelioid mesothelioma who are able to proceed with surgery after neoadjuvant ipilimumab and nivolumab. II. To determine the progression-free survival rate at 12 months after the initiation of neoadjuvant ipilimumab and nivolumab. SECONDARY OBJECTIVES: I. To determine the rate of intra-operative or post-operative complications following neoadjuvant immunotherapy. II. Best response per modified pleural Response Evaluation Criteria in Solid Tumors (RECIST). III. Major pathologic response rate. IV. Time to recurrence after surgery. EXPLORATORY OBJECTIVES: I. To evaluate the association between the change in peripheral T cell clonality relative to baseline and treatment response. II. To evaluate the association between PD-L1 expression at baseline and treatment response. III. To evaluate whether a novel mesothelioma immune signature identified by Dr. Mansfield's laboratory is predictive of response. OUTLINE: Patients receive nivolumab intravenously (IV), ipilimumab IV, and may undergo surgery on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and positron emission tomography (PET) throughout the trial.

Conditions

• Pleural Biphasic Mesothelioma
• Pleural Sarcomatoid Mesothelioma

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV
BIOLOGICAL	Ipilimumab	Given IV
PROCEDURE	Surgical Procedure	Undergo surgery
PROCEDURE	Computed Tomography	undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Positron Emission Tomography	Undergo PET

Timeline

• Start date: 2024-11-27
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2022-12-12
• Last updated: 2026-03-04

Locations

131 sites across 1 country: United States