A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
NCT03238638 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2018-01-04
Summary
This is a research study to test the combination of two drugs, pembrolizumab and epacadostat with the goal of benefiting subjects with head and neck cancers where prior or ongoing regimens with a PD-1 or PD-L1 inhibitor for the treatment of advanced head and neck cancer after platinum failure.
Conditions
Interventions
- DRUG
-
Both cohorts will receive pembrolizumab at a flat dose of 200mg every 3 weeks.
- DRUG
-
epacadostat
Both cohorts will receive epacadostat. Patients in cohort 1 will take 300mg of epacadostat by mouth twice per day. Cohort 2 will take 300mg of epacadostat every 6 weeks.
Sponsors & Collaborators
-
University of Chicago
lead OTHER
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-30
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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