Study on Durvalumab and Tremelimumab with or without Chemotherapy for Mesothelioma

Sponsor: Baylor College of Medicine

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05932199

Provider View

This clinical trial is testing whether combining immunotherapy drugs, with or without chemotherapy, can improve outcomes for patients with mesothelioma, a type of cancer affecting the lining of the lungs.

Patient Parameters

Program Overview

The study aims to find out if using a combination of immunotherapy drugs, durvalumab and tremelimumab, with or without chemotherapy, can help patients with mesothelioma live longer without the cancer coming back. Researchers will also look at how safe these treatments are and whether they improve the chances of removing the cancer through surgery.

Description

This study involves two groups of patients with mesothelioma, a cancer affecting the lining of the lungs. One group will receive a combination of immunotherapy drugs, durvalumab and tremelimumab, while the other group will receive these drugs along with chemotherapy. The goal is to see if these treatments can help patients live longer without the cancer returning and if they make it easier to remove the cancer through surgery.

The study will start with a small number of patients to check the safety of the treatments. If the treatments are safe, more patients will be added to the study. Patients will continue to receive durvalumab for up to a year after surgery, and tremelimumab will be given for up to five cycles. The study will include a total of 52 patients to account for any who may not be able to complete the study.

Eligibility Criteria

Inclusion Criteria

  • Have mesothelioma that can potentially be removed by surgery.
  • Be 18 years or older.
  • Have a good overall health status, allowing for normal daily activities.
  • Have normal organ and bone marrow function based on specific blood tests.
  • Women must not be pregnant and must agree to use effective birth control during the study.
  • Be willing to follow the study procedures and attend all scheduled visits.

Exclusion Criteria

  • Have participated in another clinical study within the last 3 months.
  • Have received any previous treatment with PD1 or PD-L1 inhibitors.
  • Have unresolved side effects from previous cancer treatments.
  • Have a history of severe allergic reactions to similar drugs.
  • Have active infections or other serious medical conditions that could interfere with the study.
  • Be pregnant or breastfeeding, or not using effective birth control if of reproductive potential.
  • Have uncontrolled brain metastases or seizures.

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