Baylor College of Medicine is recruiting patients for a PHASE1/PHASE2 clinical trial testing immunotherapy for mesothelioma.
The trial, designated NCT05932199, aims to enroll up to 52 participants at 2 sites, including locations in North Carolina, Texas.
About the Study
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:
- 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.
- 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.
Treatment Approach
This trial uses checkpoint inhibitor immunotherapy.
Key trial details:
- Phase: PHASE1/PHASE2
- Sponsor: Baylor College of Medicine
- Enrollment target: 52
- Status: RECRUITING
Why This Trial Matters
Study Locations
The trial is recruiting at:
- Duke Cancer Institute, North Carolina
- Baylor St Lukes, Texas
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening