Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.

Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.

Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.

Retifanlimab 500mg will be administered intravenously every 4 weeks.

Retifanlimab

INCAGN02385 350mg will be administered intravenously every 2 weeks.

INCAGN02385

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

INCAGN02390

Placebo will be administered intravenously.

Placebo

Incyte Corporation Call Center (US)

Incyte Corporation Call Center (ex-US)

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).

Patients will be randomized to 1 of 3 treatment groups.

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

A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Defined as the interval between the date of first dose of study treatment and the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death due to any cause.

Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.

Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.

Defined as having CR, PR, or SD (≥ 6 months) as best response, based on investigator assessment per RECIST v1.1.

Defined as the interval between the date of the date of first dose of study treatment until death due to any cause.

TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Head and Neck C...	Retifanlimab INCAGN02385 INCAGN02390 Placebo	18 Years - 99 Years	Incyte Corporation
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	Head and Neck C...	Retifanlimab INCAGN02385 INCAGN02390 Placebo	18 Years - 99 Years	Incyte Corporation

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