Tremelimumab (Anti-CTLA-4) Plus MEDI4736 (Anti-PD-L1) in Resectable Colorectal Cancer Liver Metastases
|Colorectal Cancer Liver Metastases||Drug: Tremelimumab Drug: MEDI4736 Procedure: Liver Resection||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Pilot Study Assessing the Safety and Tolerability of the Neoadjuvant Use of Tremelimumab (Anti-CTLA-4) Plus MEDI4736 (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver Metastases|
- Feasibility of Tremelimumab plus MEDI4736 with FOLFOX and Bevacizumab in Candidates for Resection of Colorectal Cancer Liver Metastases [ Time Frame: 15 weeks ]Feasibility assessed by whether or not the patient successfully goes to surgery following the planned treatments, scans, and biopsy. Combination regimen considered feasible if at least 80% of patients successfully undergo surgery. It will be infeasible if fewer than 60% of patients can undergo surgery.
- Relapse-free survival (RFS) of Tremelimumab plus MEDI4736 with FOLFOX and Bevacizumab in Candidates for Resection of Colorectal Cancer Liver Metastases [ Time Frame: 56 weeks ]Relapse-free survival (RFS) assessed from the date of study entry until relapse or death from any cause.
|Actual Study Start Date:||July 28, 2016|
|Estimated Study Completion Date:||July 2021|
|Estimated Primary Completion Date:||July 2021 (Final data collection date for primary outcome measure)|
Experimental: Tremelimumab + MEDI4736
Participants receive Tremelimumab by vein over about 1 hour and MEDI4736 by vein over about 4 hours during Week 11. After Week 11, participants receives MEDI4736 alone by vein over about 1 hour during Weeks 21, 25, 29, and 33.
Between Weeks 15 and 17, participant undergoes scheduled liver surgery.
Tremelimumab 75 mg by vein as a flat dose during Week 11.Drug: MEDI4736
MEDI4736 1500 mg by vein as a flat dose during Week 11. After Week 11, participant receives MEDI4736 alone by vein during Weeks 21, 25, 29, and 33.
Other Name: DurvalumabProcedure: Liver Resection
Participant undergoes scheduled liver resection between Weeks 15 and 17.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02754856
|Contact: Michael Overman, MD||713-792-2828|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Overman, MD||M.D. Anderson Cancer Center|