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Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
Address: 20 Duke Medicine Cir, Durham, NC 27710, USA
Phone: 877-451-7009
Mesothelioma Type:
- Pleural: True
- Peritoneal: False
- Pericardial: False
- Tunica Vaginalis: False
Type: Epitheliod, Sarcomatoid, Biphasic
Condition: Mesothelioma
Description: "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."
Research Center: Duke Cancer Institute
Treatment Interventions: DRUG: Durvalumab / tremelimumab, DRUG: Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab
Potential Impact: Fake Data
Clinical Trial Number: NCT05932199
Phase: Phase 2, Phase 1
Status: Recruiting
