Study on Pembrolizumab for Treating Malignant Mesothelioma

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02399371

Provider View

This clinical trial is exploring how well the drug pembrolizumab works in treating malignant mesothelioma, a type of cancer affecting the lining of the lungs or abdomen. Pembrolizumab is a monoclonal antibody that may help the immune system attack and kill cancer cells.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of pembrolizumab in patients with malignant mesothelioma, a cancer that affects the lining around the lungs (pleura) or abdomen (peritoneum). Pembrolizumab is a type of monoclonal antibody that blocks a protein called PD-1, potentially boosting the immune system's ability to fight cancer cells.

Description

The main goals of this study are to see how well pembrolizumab works in shrinking tumors in patients with malignant mesothelioma, both in general and in those whose tumors have a specific marker called PD-L1. Researchers will also look at how long patients live without the disease getting worse and their overall survival rates. They will assess the safety of pembrolizumab and how many patients have tumors with the PD-L1 marker.

The study will also explore the immune environment in the tumors and how pembrolizumab affects it. This includes looking at specific immune cells and proteins that might help the cancer evade the immune system.

Participants will receive pembrolizumab through an IV every three weeks for up to two years, as long as the cancer does not progress and side effects are manageable. If the cancer returns after stopping pembrolizumab, patients may be eligible for an additional year of treatment.

After finishing the treatment, patients will be monitored regularly to check for any disease progression or side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with malignant mesothelioma affecting the lining of the lungs or abdomen.
  • Cancer has progressed after treatment with pemetrexed and a platinum-based drug.
  • No more than two previous chemotherapy treatments.
  • Willing to provide informed consent and follow study procedures.
  • Have measurable cancer based on specific medical criteria.
  • Provide a tissue sample from a tumor for analysis.
  • Be in good overall health with a performance status of 0 or 1.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 120 days after the last dose.
  • Men must agree to use contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Currently in another clinical trial or have been in one recently.
  • Have unresolved side effects from previous treatments.
  • Have an immune deficiency or are on immunosuppressive therapy.
  • Have had recent treatment with certain antibodies or chemotherapy.
  • Have another active cancer requiring treatment.
  • Have untreated or unstable brain metastases.
  • Have an active autoimmune disease requiring treatment.
  • Have lung disease or active infection needing treatment.
  • Have a condition that could interfere with the study.
  • Are pregnant or breastfeeding.
  • Have received certain immune therapies before.
  • Have active hepatitis B or C, or HIV.
  • Have had a live vaccine recently.

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