Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Study ID
- NCT03982173
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Esophageal Adenocarcinoma
- Metastatic Colorectal Cancer
- Prostate Adenocarcinoma
- Stomach Adenocarcinoma
- Triple Negative Breast Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tremelimumab — DRUGtremelimumab 75mg
- Durvalumab — DRUGDurvalumab 1500mg
Study Details
To determine the efficacy (as measured by overall tumour response rate) of the combination of durvalumab and tremelimumab when given to previously treated patients with solid tumors harboring a high mutational load.
Key Dates
- Start date
- Sep 30, 2020
- Status verified
- Jan 2023
- Primary completion
- Sep 30, 2024
- Completion
- Dec 5, 2024
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: previously treated patients with solid tumorspreviously treated patients with solid tumors harboring a high mutational load.
Primary Outcome Measure
Objective tumour response rate [ Time Frame: at 12 weeks ]
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