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Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT05287113 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-03-27

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

Conditions

Interventions

DRUG

Retifanlimab

Retifanlimab 500mg will be administered intravenously every 4 weeks.

DRUG

INCAGN02385

INCAGN02385 350mg will be administered intravenously every 2 weeks.

DRUG

INCAGN02390

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

DRUG

Placebo

Placebo will be administered intravenously.

Sponsors & Collaborators

  • Incyte Biosciences International Sàrl

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2025-03-14
Completion
2026-07-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Georgia
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287113 on ClinicalTrials.gov