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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 176
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •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.
研究组 & 干预措施
Treatment Group 1: Retifanlimab Monotherapy
Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
干预措施: Retifanlimab (Drug)
Treatment Group 1: Retifanlimab Monotherapy
Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
干预措施: Placebo (Drug)
Treatment Group 2: Retifanlimab + INCAGN02385
Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
干预措施: Retifanlimab (Drug)
Treatment Group 2: Retifanlimab + INCAGN02385
Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
干预措施: INCAGN02385 (Drug)
Treatment Group 2: Retifanlimab + INCAGN02385
Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
干预措施: Placebo (Drug)
Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
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.
干预措施: Retifanlimab (Drug)
Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
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.
干预措施: INCAGN02385 (Drug)
Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
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.
干预措施: INCAGN02390 (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 24 months
Defined as the interval between the date of first dose of study treatment and the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death due to any cause.
次要结局
- Duration of Response (DOR)(Up to 24 months)
- Disease Control Rate (DCR)(Up to 24 months)
- Objective Response Rate (ORR)(Up to 24 months)
- Overall Survival (OS)(Up to 36 months)
- Participants with treatment-emergent adverse events (TEAE)(Up to 24 months)