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A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy

Head and Neck Cancer Clinical Trial

Official title:
A Phase II Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy

Clinical Trial 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.

Clinical Trial Description

Primary Objective(s) & Hypothesis

(1) Objective: Response Rate

Hypotheses:

Cohort 1: In patient with prior response to anti-PD-1/PD-L1+ therapy and subsequent (acquired) resistance combined IDO1 and PD-1 inhibition will re-induce responses.

Cohort 2: In patients with suboptimal benefit from prior anti-PD-1/PD-L1 therapy combined IDO1 and PD-1 inhibition will induce clinically meaningful responses.

Secondary Objective(s) & Hypothesis

1. Objective: 1-year Progression-free (PFS) and Overall (OS) survival Hypothesis: Combined PD-1 blockade with pembrolizumab + epacadostat in HNSCC patients will lead to improved 1-year survival in patients who a) progress on prior anti-PD-1/PD/L1 therapy on, and/or b) compared to patients who progress on 2nd line chemotherapy.

2. Safety Hypothesis: Combined treatment with pembrolizumab and epacadostat will be safe and tolerable in HNSCC patients.

Exploratory/Translational Objectives

1. Interferon-gamma Gene Expression Profile (GEP) (Seiwert ASCO 2015, Ribas ASCO 2015) and evaluation of RR, PFS, and OS in GEP positive and GEP negative patients.

2. Determine the micro-environment that underlies resistance/suboptimal treatment

1. underlying degree of tumor inflammation

2. Baseline PD-L1 expression

d) Determine underlying Interferon Gamma signature

3. Assess underlying mutational burden (Snyder 2014)) Preclinical hypothesis: IDO1 inhibition will alter the micro-environment to a be "more T-cell inflamed" and make tumors amenable to benefit from anti-PD-1 treatment (when given concurrently with IDO1 inhibition). Hence we will evaluate tumors, with prior response exhibiting acquired resistance as well as tumors with minor/suboptimal benefit from prior PD-1/PD-L1 therapy for evidence (at baseline) of suboptimal immune microenvironmental conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03238638
Study type Interventional
Source University of Chicago
Contact
Status Withdrawn
Phase Phase 2
Start date September 2018
Completion date December 2020
View Details
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