RecruitingPhase 1Phase 2NCT05932199

Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma

Combination of Induction Durvalumab and Tremelimumab Alone Versus Durvalumab and Tremelimumab With Chemotherapy for Potentially Resectable Pleural Mesothelioma


Sponsor

Baylor College of Medicine

Enrollment

52 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Objectives: The investigators will test whether combination of chemoimmunotherapy or dual agent immunotherapy alone improves efficacy for patients with MPM. Primary Objectives: The primary objective is to test whether the combination of platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves recurrence-free survival for patients with resectable MPM compared to historical, published data for surgery with chemotherapy. Secondary Objective(s): The secondary objectives are to determine the safety of and whether the platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves response rate, resectability, major pathological response, and complete pathological response. Exploratory Objective(s): The exploratory objectives are to determine the safety of and whether the platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves response rate, resectability, major pathological response, and complete pathological response for patients with epithelioid and non-epithelioid histologies. The scientific exploratory objectives include: 1. Develop an NGS plasma assay of common mutations identified from our previous grant cycle to prospectively measure minimal residual disease (MRD) after resection as a potential, novel biomarker test in mesothelioma. 2. Determine the predictive role of BH3 profiling in patients undergoing neoadjuvant ICI followed by surgery: With patient samples collected from our neoadjuvant ICI trial, the investigators will test whether BH3 profiling from pre-treatment tumor biopsies and PBMC predicts clinical, radiological, and pathological responses to ICIs. The investigators will identify TAMs from the TiME in MPM tumor samples before and after treatment to compare differences in polarization induced by ICI in clinical and pathologically responding versus non-responding patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two immunotherapy drugs — durvalumab and tremelimumab — given before surgery to treat mesothelioma, a type of cancer that lines the lungs. These drugs help the immune system fight cancer. Some patients will also receive chemotherapy alongside the immunotherapy. **You may be eligible if...** - You are over 18 years old - You have mesothelioma that doctors believe can be surgically removed - Your cancer has not spread beyond the affected lung lining - You are in good general health (able to carry out daily activities) - Your blood counts, liver, and kidney function meet required levels - You have not previously received PD-1 or PD-L1 immunotherapy (like durvalumab) **You may NOT be eligible if...** - You have taken immunosuppressive medication recently (within 28 days) - You have a history of severe autoimmune disease, organ transplant, or HIV/AIDS - You are pregnant or breastfeeding - You have uncontrolled heart disease or active serious infections - You previously had severe immune-related side effects from cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab / tremelimumab

Durvalumab concentrate for solution for infusion will be supplied in glass vials containing 500 mg durvalumab at a concentration of 50 mg/mL. Tremelimumab concentrate for solution for infusion will be supplied in glass vials containing 400 mg or 25 mg tremelimumab at a concentration of 20 mg/mL.

DRUGPlatinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab

Cisplatin 75mg/ m2 (or carboplatin AUC 5-6) + pemetrexed 500 mg/m2 will be provided as per standard of care. Durvalumab concentrate for solution for infusion will be supplied in glass vials containing 500 mg durvalumab at a concentration of 50 mg/mL. Tremelimumab concentrate for solution for infusion will be supplied in glass vials containing 400 mg or 25 mg tremelimumab at a concentration of 20 mg/mL.


Locations(2)

Duke Cancer Institute

Durham, North Carolina, United States

Baylor St Lukes

Houston, Texas, United States

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NCT05932199


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