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Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

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Incyte

Status and phase

Active, not recruiting
Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: INCAGN02390
Drug: Retifanlimab
Drug: Placebo
Drug: INCAGN02385

Study type

Interventional

Funder types

Industry

Identifiers

NCT05287113
INCAGN 2385-203

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

Enrollment

176 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent. Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible.
  • Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
  • Participants must not have received prior systemic therapy for R/M SCCHN.
  • PD-L1 positive tumor status defined by CPS ≥ 1% per central laboratory determination.
  • For participants with primary oropharyngeal tumors, documentation of HPV p16 status based on local institutional standard is required. HPV p16 status is not required for other eligible SCCHN primary tumor sites.
  • Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
  • Availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy.
  • ECOG performance status of 0 or 1.
  • Willingness to avoid pregnancy or fathering children.

Exclusion criteria

  • Progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced SCCHN. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint inhibitor therapy, for SCCHN or any other malignancy.
  • Treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment.
  • Presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding.
  • Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and are excluded.
  • Less than 3-month life expectancy.
  • Participant has not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
  • Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment.
  • 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.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

176 participants in 3 patient groups

Treatment Group 1: Retifanlimab Monotherapy
Experimental group
Description:
Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
Treatment:
Drug: Placebo
Drug: Retifanlimab
Treatment Group 2: Retifanlimab + INCAGN02385
Experimental group
Description:
Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
Treatment:
Drug: INCAGN02385
Drug: Placebo
Drug: Retifanlimab
Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
Experimental group
Description:
Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.
Treatment:
Drug: INCAGN02385
Drug: INCAGN02390
Drug: Retifanlimab

Trial contacts and locations

91

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Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

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