NCT04634825终止2 期
A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- MacroGenics
- 入组人数
- 62
- 试验地点
- 83
- 主要终点
- ORR of Enoblituzumab Plus Tebotelimab
研究概览
简要总结
This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) not curable by local therapy
- •No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease)
- •Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx (any histology)
- •Availability of formalin-fixed, paraffin embedded tumor specimen or contemporary biopsy for immunohistochemical evaluation of pharmacodynamic markers of interest
- •Willing to consent for baseline and on-treatment biopsy.
- •Performance status 0 or 1
- •Life expectancy of 6 months or more
- •Adequate end organ function
- •At least one radiographically measurable lesion
- •PD-L1 expression level that is either
- •Positive (combined positive score [CPS] ≥ 1) for the retifanlimab cohort, or
- •Negative (CPS < 1) for the tebotelimab cohort
- •Results available from human papilloma virus p16 status for oropharyngeal cancer
- •Acceptable laboratory results
排除标准
- •Disease suitable for local therapy administered with curative intent
- •Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN
- •Radiation or other non-systemic therapy within 2 weeks prior to the first dose of study drug
- •Prior therapy with an anti-B7-H3, anti-PD-1, anti-PD-L1, or anti-LAG-3 agent
结局指标
主要结局
ORR of Enoblituzumab Plus Tebotelimab
时间窗: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
Investigator-assessed ORR. ORR, defined as the percentage of patients in the response evaluable population who achieve the a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
时间窗: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.
Investigator-assessed ORR. defined as the percentage of patients in the response evaluable population who achieve the best overall response of complete response (CR) or partial response (PR),per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions
Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab
时间窗: Throughout the study, up to 16.5 months.
次要结局
- Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)(Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days))
- Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)(Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days))
- Trough Concentration of Tebotelimab (Ctrough or Cmin)(Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days))
- Trough Concentration of Retifanlimab (Ctrough or Cmin)(Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days))
- Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab.(Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months)
- Disease-control Rate (DCR)(Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months)
- Overall Survival(up to 16.5 months)
- Best Overall Response (BOR)(Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months)
- Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)(Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days))
- Number of Patients Who Develop ADA to Tebotelimab(Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months)
- Number of Patients Who ADA to Retifanlimab(Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months)
- Progression-free Survival (PFS)(Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months)
- Duration of Response(Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months)
- Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab(Throughout the study, up to 16.5 months.)
- Trough Concentration of Enoblituzumab (Ctrough or Cmin)(Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
研究者
研究点 (83)
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