BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer
Part of paid clinical trials in Sacramento, California.
- Sponsor
- Edward Kim
- Study ID
- NCT03695250
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
- Metastatic Hepatocellular Carcinoma
- Stage III Hepatocellular Carcinoma AJCC v8
- Stage IIIA Hepatocellular Carcinoma AJCC v8
- Stage IIIB Hepatocellular Carcinoma AJCC v8
- Stage IV Hepatocellular Carcinoma AJCC v8
- Stage IVA Hepatocellular Carcinoma AJCC v8
- Stage IVB Hepatocellular Carcinoma AJCC v8
- Unresectable Hepatocellular Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IDO1 Inhibitor BMS-986205 — DRUGGiven PO
- Nivolumab — BIOLOGICALGiven IV
Study Details
This phase I/II trial studies the side effects and best dose of IDO1 inhibitor BMS-986205 (BMS-986205) when given together with nivolumab and how well it works as first or second line therapy in treating patients with liver cancer. BMS-986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving BMS-986205 and nivolumab may work better in treating patients with liver cancer.
Key Dates
- Start date
- Oct 16, 2018
- Status verified
- Aug 2023
- Primary completion
- Nov 24, 2020
- Completion
- Mar 12, 2021
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (BMS-986205 and nivolumab)Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-14 and nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Adverse Events (AE) [ Time Frame: Up to 2 years. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | - |
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