Pembrolizumab + Epacadostat for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+72 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Eligibility Criteria

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.

Inclusion Criteria

My organs are functioning well according to the test results.

Measurable disease based on RECIST v1.1

My oropharyngeal cancer has been tested for HPV.

See 2 more

Exclusion Criteria

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

Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority

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

See 5 more

Treatment Details

Interventions

5-Fluorouracil (Anti-metabolites)
Carboplatin (Alkylating agents)
Cetuximab (Monoclonal Antibodies)
Cisplatin (Alkylating agents)
Epacadostat (IDO1 Inhibitor)
Pembrolizumab (Checkpoint Inhibitor)

Trial OverviewThe 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.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + EpacadostatExperimental Treatment2 Interventions

Group II: PembrolizumabExperimental Treatment1 Intervention

Group III: EXTREMEActive Control4 Interventions

EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.

5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as 5-FU for: