Pembrolizumab + Epacadostat for Head and Neck Cancer

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Active autoimmune disease that has required systemic treatment in past 2 years

Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial found that pembrolizumab plus epacadostat was more effective than the EXTREME regimen or pembrolizumab monotherapy for treating HNSCC.

Who is the study for?

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma who have measurable disease, are in good physical condition (ECOG 0-1), have proper organ function, and can provide a tumor specimen. It's not for those with recent other cancers, active autoimmune diseases treated within the last 2 years, HIV or hepatitis B/C infections, CNS metastases, or certain types of head and neck cancer.

What is being tested?

The study compares three treatments: pembrolizumab plus epacadostat; pembrolizumab alone; and the EXTREME regimen (cetuximab with cisplatin/carboplatin plus 5-fluorouracil). The goal is to see which treatment works best as a first-line therapy for this type of cancer.

What are the potential side effects?

Possible side effects include immune-related reactions due to pembrolizumab or epacadostat, infusion reactions from cetuximab, kidney issues from cisplatin/carboplatin use, mouth sores and low blood counts from 5-fluorouracil. Each patient may experience different side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My oropharyngeal cancer has been tested for HPV.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated for an autoimmune disease in the last 2 years.

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My cancer originates from the nasopharynx, salivary gland, or is of an unknown primary origin.

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I have cancer that has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen

Secondary study objectives

Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs

Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)