Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

Incyte

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer

Treatments: Drug: Pembrolizumab; Drug: Cetuximab; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: Epacadostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03358472

KEYNOTE-669/ECHO 304

2017-001338-24 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Measurable disease based on RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function per protocol-defined criteria.
• Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
• Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen.

Exclusion criteria

• Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
• Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
• Use of protocol-defined prior/concomitant therapy.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Active autoimmune disease that has required systemic treatment in past 2 years.
• Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
• Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is detected).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 3 patient groups

Pembrolizumab + Epacadostat

Experimental group

Treatment:

Drug: Epacadostat

Drug: Pembrolizumab

Pembrolizumab

Experimental group

Treatment:

Drug: Pembrolizumab

EXTREME

Active Comparator group

Description:

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

Treatment:

Drug: 5-Fluorouracil

Drug: Cisplatin

Drug: Carboplatin

Drug: Cetuximab