A Phase 3 randomized clinical Study of Pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen as first line treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Phase 1

Conditions: Histologically or cytologically-confirmed Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma that is considered incurable by local therapies
MedDRA version: 22.0Level: LLTClassification code: 10082179Term: Squamous cell carcinoma of head and neck metastatic Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-512015-47-00

Lead Sponsor: Incyte Corp.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

Participants with histologically or cytologically-confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx., 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 Head and Neck Squamous Cell Carcinoma (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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate ORR of pembrolizumab + epacadostat, pembrolizumab monotherapy, and the EXTREME regimen based on RECIST 1.1 by investigator determination.;Secondary Objective: To evaluate the safety and tolerability of the 3 treatment groups.;Primary end point(s): Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs);Secondary end point(s):Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs