A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 204
- 主要终点
- Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
研究概览
简要总结
A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
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
- Double (Participant, Investigator)
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
- •Confirmed squamous cell head and neck cancer
- •Widespread (metastatic) disease, or returned after previous treatment (recurrent)
- •Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]
- •Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)
排除标准
- •Previous treatment for metastatic or recurrent disease
- •Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
- •Any non-squamous subtype
- •Active autoimmune disease
- •Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
- •Previous treatment with checkpoint inhibitor drugs
- •Active CNS metastases or carcinomatous meningitis
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
时间窗: Approximately up to 30 months (from FPFV to Data base lock)
ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
时间窗: Approximately up to 30 months (from FPFV to Data base lock)
The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.
Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
时间窗: Approximately up to 30 months (from FPFV to Data base lock)
Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup(From randomization to disease progression or death. Approximately 63 Months)
- Overall Survival (OS) - Platinum Refractory Subgroup(From randomization to death. Approximately 63 Months)
- Overall Survival (OS)(From randomization to death. Approximately 63 Months)
- Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup(From randomization to disease progression or death. Approximately 63 Months)
- ORR - Platinum Eligible Subgroup Based on HPV p-16 Status(From randomization to end of study. Approximately 63 Months)
- ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker(From randomization to end of study. Approximately 63 Months)
- Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup(From randomization to end of study. Approximately 63 Months)
- Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup(From randomization to disease progression or death. Approximately 63 Months)
- ORR - Platinum Refractory Subgroup Based on HPV p-16 Status(From randomization to end of study. Approximately 63 Months)
- ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker(From randomization to end of study. Approximately 63 Months)
- Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status(From randomization to disease progression or death. Approximately 63 Months)
- Overall Survival (OS) - Platinum Eligible Subgroup(From randomization to death. Approximately 63 Months)
- Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status(From randomization to disease progression or death. Approximately 63 Months)
- Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status(From randomization to disease progression or death. Approximately 63 Months)
- Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status(From randomization to disease progression or death. Approximately 63 Months)
- Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status(From randomization to death. Approximately 63 Months)
- Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status(From randomization to death. Approximately 63 Months)
- Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status(From randomization to death. Approximately 63 Months)
- Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status(From randomization to disease progression or death. Approximately 63 Months)
- Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status(From randomization to disease progression or death. Approximately 63 Months)
- Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status(From randomization to disease progression or death. Approximately 63 Months)
- Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status(From randomization to death. Approximately 63 Months)
- Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status(From randomization to death. Approximately 63 Months)
- Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status(From randomization to disease progression or death. Approximately 63 Months)
- Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status(From randomization to disease progression or death. Approximately 63 Months)
- Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status(From randomization to disease progression or death. Approximately 63 Months)
- Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status(From randomization to disease progression or death. Approximately 63 Months)
- Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status(From randomization to disease progression or death. Approximately 63 Months)
- ORR - Platinum Refractory Subgroup Based on PD-L1 Expression(From randomization to end of study. Approximately 63 Months)
- Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status(From randomization to death. Approximately 63 Months)
- ORR - Platinum Eligible Subgroup Based on PD-L1 Expression(From randomization to end of study. Approximately 63 Months)