A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS >= 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Head and neck cancermetastatic10027476
- Registration Number
- NL-OMON53614
- Lead Sponsor
- Incyte Biosciences International Sarl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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
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 <= Grade 1 or baseline from residual
toxicities of prior therapy (with exceptions for anemia not requiring
transfusion support, fatigue, or any grade of alopecia).
7. Participant has not recovered adequately from toxicities and/or
complications from surgical intervention before starting study treatment.
8. Palliative radiation therapy administered within 1 week before the first
dose of study treatment or radiation therapy in the thoracic region that is >
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 < 4 weeks since radiation therapy was delivered
to the CNS.
10. Participants with laboratory values at screening as defined
11. Has known active HBV or HCV, defined as follows (testing must be performed
to determine eligibility):
a. Active HBV is defined as a known positive HBsAg result and positive total
anti-HBc results. Note: When HBsAg is negative AND HBcAb and/or
HBsAb is positive, HBV-DNA should be measured. When HBV-DNA is negative, this
participant could be enrolled with close monitoring of HBV activities.
b. Active HCV is defined as a positive HCV antibody result and quantitative
HCV-RNA results greater than the lower limits of detection of the assay. Note:
Participants positive for HCV antibody will be eligible if they are negative
for HCV-RNA. Participants who have had definitive treatment for HCV are
permitted if HCV-RNA is undetectable.
12. Participants who are known to be HIV-positive, unless all of the following
criteria are met:
a. CD4+ count >= 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method