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NCT05932199 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
A Phase 1 study of Mesothelioma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 2
- Study locations
NCT05932199: Recruiting Phase 1 study of Mesothelioma, sponsored by Baylor College of Medicine.
NCT05932199 is a Phase 1 study of Mesothelioma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 52 participants, below the 197-participant average among 46 other Mesothelioma trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05932199, a Phase 1 study of Mesothelioma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 2
- Study locations
Study Summary
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
Primary Outcome
Recurrence-free survival of greater than 60% at one year.
Conditions Studied
Interventions
- DRUG Durvalumab / tremelimumab
- DRUG Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab
Study Locations (2)
North Carolina
- Duke Cancer Institute - Durham
Texas
- Baylor St Lukes - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-07-03 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
What NCT05932199 shows while recruiting
NCT05932199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 197-participant average among 46 other Mesothelioma trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Mesothelioma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab / tremelimumab is the first listed.
NCT05932199 reports a single indexed study location in North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT05932199 about?
NCT05932199 is a clinical study titled "Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma". 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 / ...
What is the current status of trial NCT05932199?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2024-07-03. Estimated completion is 2028-05-31.
What conditions does trial NCT05932199 study?
This clinical trial studies the following conditions: Mesothelioma.
What interventions are being tested in trial NCT05932199?
The interventions under investigation include: Durvalumab / tremelimumab (DRUG), Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab (DRUG).
Who is sponsoring clinical trial NCT05932199?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05932199 being conducted?
This trial has 2 study locations across North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05932199's enrollment target sits among peer trials
52 33rd of 46 higher than 14 of 46 other Mesothelioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mesothelioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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