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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
176
Retifanlimab 500mg will be administered intravenously every 4 weeks.
INCAGN02385 350mg will be administered intravenously every 2 weeks.
INCAGN02390 400 mg will be administered intravenously every 2 weeks.
Placebo will be administered intravenously.
Mayo Clinic Rochester
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope Orange County
Irvine, California, United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
City of Hope-Antelope Valley
Lancaster, California, United States
Progression Free Survival (PFS)
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.
Time frame: Up to 24 months
Objective Response Rate (ORR)
Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.
Time frame: Up to 24 months
Duration of Response (DOR)
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.
Time frame: Up to 24 months
Disease Control Rate (DCR)
Defined as having CR, PR, or SD (≥ 6 months) as best response, based on investigator assessment per RECIST v1.1.
Time frame: Up to 24 months
Overall Survival (OS)
Defined as the interval between the date of the date of first dose of study treatment until death due to any cause.
Time frame: Up to 36 months
Participants with treatment-emergent adverse events (TEAE)
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
Time frame: Up to 24 months
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Innovative Clinical Research Institute
Long Beach, California, United States
City of Hope National Medical Center
Long Beach, California, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
...and 81 more locations