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NCT03238638 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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

No results posted yet for this study

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

Pembrolizumab

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238638 on ClinicalTrials.gov