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).
The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab in participants with GITR expression in recurrent or metastatic HNSCC who have progressed on or after prior systemic therapy including anti-PD-(L)1 therapy. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
retifanlimab will be administered via IV Q4W
Uab Medicine-the Kirklin Clinic
Birmingham, Alabama, United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Time frame: Screening through 90 days after end of treatment, up to 24 months
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Defined as the percentage of participants having complete response (CR) or partial response (PR).
Time frame: Assessed every 8 weeks for 12 months, thereafter every 12 weeks up to the end of treatment, up to 24 months.
Duration of response (DOR) based on RECIST v1.1 and mRECIST
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
Time frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Disease control rate (DCR) based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having CR, PR, or stable disease (SD).
Time frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Progression-free survival (PFS) based on RECIST v1.1 and mRECIST
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
Time frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
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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
...and 7 more locations
Time frame: Screening through 90 days after end of treatment, up to 24 months