Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Baylor College of Medicine
Study ID
NCT05932199
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Durvalumab / tremelimumab — DRUG
    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.
  • Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction dual immunotherapy with durvalumab / tremelimumab
    3 cycles of durvalumab (1500 mg intravenously) + tremelimumab (75 mg intravenously) starting Cycle1 Day (Cohort A).
  • Experimental: Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab
    3 cycles of durvalumab (1500 mg intravenously) + tremelimumab (75 mg intravenously) with cisplatin 75mg/ m2 (or carboplatin AUC 5-6) + pemetrexed 500 mg/m2 (Cohort B).

Primary Outcome Measure

Recurrence-free survival of greater than 60% at one year. [ Time Frame: Recurrence-free survival of greater than 60% at one year. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27710
Jeffrey Clarke, MD
[email protected]
919-660-9674
Baylor St LukesHoustonTexas77030
Monica Vilchis
[email protected]
713-798-5530
Robert Ripley, MD
[email protected]
713-798-6376
Robert Ripley, MD (PRINCIPAL_INVESTIGATOR)

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