INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Biosciences International Sàrl
Study ID
NCT05359692
Phase
PHASE2
Status
Withdrawn

Conditions

  • Advanced Malignancies
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • INCAGN01876 — BIOLOGICAL
    INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
  • retifanlimab — BIOLOGICAL
    retifanlimab will be administered via IV Q4W

Study Details

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2).

Key Dates

Start date
Mar 1, 2023
Status verified
Sep 2023
Primary completion
Apr 20, 2024
Completion
Jan 11, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Cohort 1
    INCAGN01876 every 2 weeks (Q2W) with retifanlimab every 4 weeks (Q4W).
  • Experimental: Part 1: Cohort 2
    INCAGN01876 Q2W with retifanlimab Q4W.
  • Experimental: Part 2 (Expansion): Treatment Group A
    INCAGN01876 and retifanlimab combination in participants who have been previously treated with anti-PD-(L)1 therapy.
  • Experimental: Part 2 (Expansion): Treatment Group B
    INCAGN01876 and retifanlimab combination in participants who are naive to anti-PD-(L)1 therapy.

Primary Outcome Measure

Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Screening through 90 days after end of treatment, up to 24 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
Uab Medicine-the Kirklin ClinicBirminghamAlabama35233-
University of California San Diego Medical Center, Moores Cancer CenterLa JollaCalifornia92093-
Stanford UniversityPalo AltoCalifornia94304-
Toi Clinical ResearchWhittierCalifornia90603-
University of ChicagoChicagoIllinois60637-
University of Kansas Cancer CenterWestwoodKansas66205-
Norton Cancer InstituteLouisvilleKentucky40202-
University of Maryland-Greenebaum Cancer CenterBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
John Theurer Cancer Center, Hackensack University Medical CenterHackensackNew Jersey07601-
Mount Sinai PrimeNew YorkNew York10029-
University of Cincinnati Cancer InstituteCincinnatiOhio45219-
Providence Portland Med. CtrPortlandOregon97213-
Md Anderson Cancer CenterHoustonTexas77030-
University of UtahSalt Lake CityUtah84112-
The Adult Outpatient Pavilion At VcuRichmondVirginia23219-

Find similar trials in Birmingham, AL

By research site
Uab Medicine-the Kirklin Clinic· Birmingham, ALUniversity of California San Diego Medical Center, Moores Cancer Center· La Jolla, CAStanford University· Palo Alto, CAToi Clinical Research· Whittier, CAUniversity of Chicago· Chicago, ILUniversity of Kansas Cancer Center· Westwood, KS

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