Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
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ClinicalTrials.gov Identifier: NCT05932199 |
Recruitment Status :
Not yet recruiting
First Posted : July 6, 2023
Last Update Posted : January 16, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | June 27, 2023 | ||||||||
First Posted Date ICMJE | July 6, 2023 | ||||||||
Last Update Posted Date | January 16, 2024 | ||||||||
Estimated Study Start Date ICMJE | January 15, 2024 | ||||||||
Estimated Primary Completion Date | May 31, 2028 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Recurrence-free survival of greater than 60% at one year. [ Time Frame: Recurrence-free survival of greater than 60% at one year. ] Recurrence-free survival of greater than 60% at one year.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma | ||||||||
Official Title ICMJE | Combination of Induction Durvalumab and Tremelimumab Alone Versus Durvalumab and Tremelimumab With Chemotherapy for Potentially Resectable Pleural Mesothelioma | ||||||||
Brief 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:
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Detailed Description | Study Design: The study will be a two-arm, randomized non-comparative Phase Ib/IIa study of induction dual immunotherapy with durvalumab/tremelimumab OR platinum chemotherapy (cisplatin or carboplatin) and pemetrexed chemotherapy plus dual immunotherapy with durvalumab/tremelimumab for 3 cycles in untreated, potentially resectable malignant pleural mesothelioma for all histologic subtypes and regardless PDL1 score. Patients will continue adjuvant durvalumab for up to 12 months following surgery. Tremelimumab will be given up to cycle 5 on treatment protocol. The investigators will enroll 6 patients to each arm to assess safety and resectability. If differences are not noted between the two arms, the investigators will expand enrollment to 23 patients per arm. To account for up to 10% unevaluable patients, the investigators will enroll at total of 52 patients. Safety in the first 6 patients in the chemotherapy plus immunotherapy arm will be determined by rate of attempted surgical resection. If 4 or more patients undergo surgical resection, then the study will proceed to enroll the full 23 patient cohort. If 3 or less than 3 patients undergo surgical resection, the study will be paused for PI review of the enrolled patients to determine causality of the safety events. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Mesothelioma | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
52 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 31, 2028 | ||||||||
Estimated Primary Completion Date | May 31, 2028 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05932199 | ||||||||
Other Study ID Numbers ICMJE | H-51512 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Robert Taylor Ripley, Baylor College of Medicine | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Baylor College of Medicine | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Duke Cancer Institute | ||||||||
Investigators ICMJE |
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PRS Account | Baylor College of Medicine | ||||||||
Verification Date | January 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |