INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT ID: NCT05359692
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-03-01
2025-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1: Cohort 1
INCAGN01876 every 2 weeks (Q2W) with retifanlimab every 4 weeks (Q4W).
INCAGN01876
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
retifanlimab
retifanlimab will be administered via IV Q4W
Part 1: Cohort 2
INCAGN01876 Q2W with retifanlimab Q4W.
INCAGN01876
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
retifanlimab
retifanlimab will be administered via IV Q4W
Part 2 (Expansion): Treatment Group A
INCAGN01876 and retifanlimab combination in participants who have been previously treated with anti-PD-(L)1 therapy.
INCAGN01876
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
retifanlimab
retifanlimab will be administered via IV Q4W
Part 2 (Expansion): Treatment Group B
INCAGN01876 and retifanlimab combination in participants who are naive to anti-PD-(L)1 therapy.
INCAGN01876
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
retifanlimab
retifanlimab will be administered via IV Q4W
Interventions
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INCAGN01876
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
retifanlimab
retifanlimab will be administered via IV Q4W
Eligibility Criteria
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Inclusion Criteria
* Documented progression on or after PD-(L)1 inhibitor alone or in combination with platinum-based chemotherapy for recurrent or metastatic HNSCC. Exception: Treatment Group B (Part 2, expansion): PD-(L)1-naïve.
* ECOG performance status of 0 to 1.
* Measurable disease based on RECIST v1.1.
* Mandatory pre-treatment and on-treatment tumor biopsies.
* GITR-positive tumor confirmed by central laboratory before study treatment start.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
* Prior treatment with any TNF Super Family agonist therapy.
* Have not recovered to ≤ Grade 1 from toxic effects of prior therapy.
* Laboratory and medical history parameters not within the Protocol-defined range before the first administration of study treatment.
Known active HBV or HCV, or Known to be seropositive for HIV.
* Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
* Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
* Known active infections requiring systemic treatment.
18 Years
99 Years
ALL
No
Sponsors
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Incyte Biosciences International Sàrl
INDUSTRY
Responsible Party
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Principal Investigators
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Nawel Bourayou, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Uab Medicine-the Kirklin Clinic
Birmingham, Alabama, United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
Stanford University
Palo Alto, California, United States
Toi Clinical Research
Whittier, California, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University of Maryland-Greenebaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Prime
New York, New York, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Providence Portland Med. Ctr
Portland, Oregon, United States
Md Anderson Cancer Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
The Adult Outpatient Pavilion At Vcu
Richmond, Virginia, United States
Countries
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Other Identifiers
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INCAGN 1876-204
Identifier Type: -
Identifier Source: org_study_id
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