Head and neck cancer
Conditions
Interventions
This is a randomized, double-blind, Phase 2 study to evaluate the efficacy and
safety of the combination of retifanlimab plus INCAGN02385(TG2) and
retifanlimab plus INCAGN02385 and INCAGN02390 (TG3)
Sponsors
Incyte Biosciences International Sarl
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Age 18 years or older (or as applicable per local country requirements), inclusive at the time of signing the ICF. 3. Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy). Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible. a. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. b.Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary gland are excluded. c.Participants must not have received prior systemic therapy for R/M SCCHN. 4. PD-L1 positive tumor status defined by CPS >= 1% per central laboratory determination. 5.For participants with primary oropharyngeal tumors, documentation of HPV p16 status (positive or negative) based on local institutional standard is required. HPV p16 status is not required for other eligible SCCHN primary tumor sites. 6.Participant must have at least 1 measurable tumor lesion per RECIST v1.1. 7.Availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy. 8.ECOG performance status of 0 or 1. 9.Willingness to avoid pregnancy or fathering children based on the criteria below: a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 180 days after the last dose of study treatment and must refrain from donating sperm during this period. b. Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 180 days after the last dose of study treatment and must refrain from donating oocytes during this period. c. Female participants not considered to be of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced SCCHN. 2. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint inhibitor therapy, for SCCHN (in any disease setting) or any other malignancy. 3. Treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment 4. Presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding. 5. Less than 3-month life expectancy (based on investigator judgement). 6. Participant has not recovered to 30 Gy within 6 months before the first dose of study treatment. 9. Known active CNS metastases and/or carcinomatous meningitis. Participants will be excluded if it has been = 300/µL. b. Undetectable viral load. c. Receiving antiretroviral therapy that is not a potential risk for a drug-drug interaction with the assigned study drug. 13. Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year after treatment with curative intent. 14. Has active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment. 15. Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent). 16. Active infections requiring systemic antibiotics or antifungal or antiviral treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the interval between the date of randomization and the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Objective response, defined as having a CR or PR, determined based on investigator assessment per RECIST v1.1. • 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. •Disease control, defined as having CR, PR, or SD (>= 6 months) as best response, based on investigator assessment per RECIST v1.1. • OS, defined as the interval between the date of randomization until death due to any cause. • AEs, assessed in body systems with symptoms, through physical examinations, changes in vital signs and ECGs, and through clinical laboratory blood sample evaluations. • Impact on study treatment, assessed by treatment interruptions, dose reductions, and withdrawal of study treatment due to AEs. | — |
Countries
Netherlands
Outcome results
None listed