OncoMatch/Clinical Trials/NCT05932199
Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
Is NCT05932199 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Durvalumab / tremelimumab and Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab for mesothelioma.
Treatment: Durvalumab / tremelimumab · Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Mesothelioma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1 inhibitor
Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
Cannot have received: PD-L1 inhibitor (durvalumab)
Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
Cannot have received: CTLA-4 inhibitor
Intolerance of anti- PD-1/PD-L1 or CTLA-4 axis drug(s), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immune-stimulatory anti-tumor agents.
Cannot have received: immunotherapy
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigational agent) <28 days
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 × 10^9/L (> 1500 per mm3); Platelet count ≥ 100 × 10^9/L (>100,000 per mm3)
Kidney function
Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation
Liver function
Serum bilirubin ≤ 1.5× institutional ULN; AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if documented liver metastases are present)
Cardiac function
Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Fredericia's Correction
Adequate normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 × 10^9/L (> 1500 per mm3); Platelet count ≥ 100 × 10^9/L (>100,000 per mm3); Serum bilirubin ≤ 1.5× institutional upper limit of normal (ULN)AST <3.0; Creatinine clearance >50mL/miN; AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if documented liver metastases are present); Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation. Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Fredericia's Correction.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke Cancer Institute · Durham, North Carolina
- Baylor St Lukes · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify