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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incyte Biosciences International Sàrl
Study ID
NCT05287113
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Retifanlimab — DRUG
    Retifanlimab 500mg will be administered intravenously every 4 weeks.
  • INCAGN02385 — DRUG
    INCAGN02385 350mg will be administered intravenously every 2 weeks.
  • INCAGN02390 — DRUG
    INCAGN02390 400 mg will be administered intravenously every 2 weeks.
  • Placebo — DRUG
    Placebo will be administered intravenously.

Study Details

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).

Key Dates

Start date
Nov 14, 2022
Status verified
Mar 2026
Primary completion
Mar 14, 2025
Completion
Jul 10, 2026

Study Design

Enrollment
176 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group 1: Retifanlimab Monotherapy
    Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
  • Experimental: Treatment Group 2: Retifanlimab + INCAGN02385
    Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
  • Experimental: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
    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.

Primary Outcome Measure

Progeression-free Survival (PFS) [ Time Frame: up to 738 days ]

Locations (24)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterScottsdaleArizona85259-
City of Hope National Medical CenterDuarteCalifornia91010-9200-
City of Hope Orange CountyIrvineCalifornia92618-
University of California San Diego Medical Center, Moores Cancer CenterLa JollaCalifornia92093-
City of Hope-Antelope ValleyLancasterCalifornia93534-
City of Hope National Medical CenterLong BeachCalifornia90813-
Innovative Clinical Research InstituteLong BeachCalifornia90805-
University of California San Francisco Comprehensive Cancer CenterSan FranciscoCalifornia94115-
Georgetown UniversityWashington D.C.District of Columbia20057-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Blessed Health CareMiamiFlorida33174-
Moffitt Cancer CenterTampaFlorida33612-9416-
University of Illinois At ChicagoChicagoIllinois60612-
University of IowaIowa CityIowa52242-1316-
University of Kansas Hospital AuthorityKansas CityKansas66103-
University of Maryland-Greenebaum Cancer CenterBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of Michigan Cancer CenterAnn ArborMichigan48109-
Barbara Ann Karmanos Cancer HospitalDetroitMichigan48201-
Hackensack University Medical CenterHackensackNew Jersey07601-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Huntsman Cancer Institute At University of UtahSalt Lake CityUtah84112-
University of Virginia - Emily Couric Clinical Cancer CenterCharlottesvilleVirginia22903-
Kadlec Clinic Hematology and OncologyKennewickWashington99336-

Find similar trials in Scottsdale, AZ

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Mayo Clinic Rochester· Scottsdale, AZCity of Hope National Medical Center· Duarte, CACity of Hope Orange County· Irvine, CAUniversity of California San Diego Medical Center, Moores Cancer Center· La Jolla, CACity of Hope-Antelope Valley· Lancaster, CACity of Hope National Medical Center· Long Beach, CA

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