Actively Recruiting
Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
Led by Baylor College of Medicine · Updated on 2025-09-25
52
Participants Needed
2
Research Sites
204 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
D
Duke Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Potentially surgically resectable malignant pleural mesothelioma (MPM) without disease beyond the ipsilateral hemithorax and no obvious invasion of chest wall or mediastinum on CT and PET scans
- Tumor evaluated as resectable by an experienced mesothelioma surgeon
- Any MPM histology including epithelial, mixed, or sarcomatoid
- N0, N1, or N2 nodal disease on preoperative chest CT or PET/CT
- Signed informed consent prior to any protocol procedures
- Age greater than 18 years at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function including hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), AST < 3.0, and creatinine clearance > 50 mL/min
- Female participants must be of non-reproductive potential or have a negative pregnancy test at entry
- Willingness and ability to comply with study protocol, including treatment and scheduled visits
- Weight greater than 30 kg
You will not qualify if you...
- Involvement in study planning or conduct or prior enrollment in this study
- Participation in another investigational clinical trial within the last 3 months
- Previous treatment with PD-1 or PD-L1 inhibitors, including durvalumab
- Receipt of any anti-cancer therapy within 28 days before study drug
- QTc interval ≥ 470 ms on ECG
- Use of immunosuppressive medication within 28 days before study drug, except low-dose corticosteroids
- Unresolved toxicity greater than grade 2 from prior anti-cancer therapy (except MPM)
- History of grade 3 or higher immune-related adverse events from prior immunotherapy or unresolved grade >1 irAE (except MPM)
- Autoimmune conditions requiring systemic immune suppression other than low-dose prednisone
- History or evidence of interstitial lung disease or pneumonitis requiring high-dose steroids
- History of primary immunodeficiency or allogeneic organ transplant
- Intolerance to immune checkpoint inhibitors or prior immune-stimulatory anti-tumor agents
- Severe or uncontrolled medical conditions compromising study participation
- Active uncontrolled infections requiring systemic treatment at study start
- History of leptomeningeal carcinomatosis
- Live attenuated vaccination within 30 days prior to study drug
- Pregnant or breastfeeding females or those not using effective contraception
- Conditions interfering with study treatment evaluation or safety interpretation
- Symptomatic or uncontrolled brain metastases requiring treatment
- Uncontrolled seizures
- No tissue available at time of thoracoscopy for study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Not Yet Recruiting
2
Baylor St Lukes
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Monica Vilchis
CONTACT
R
Robert Ripley, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here