A Phase 4, Single-arm, Open-label Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Efficacy and Safety of MK-3475 Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE B10).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 35
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Has histologically or cytologically-confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies
- •Male participants refrain from donating sperm plus are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 95 days after carboplatin/paclitaxel
- •Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or 30 days after paclitaxel or 6 months after carboplatin whichever occurs last, and agree not to donate or freeze eggs during this period
- •Has adequate organ function
排除标准
- •Has disease that is suitable for local therapy administered with curative intent
- •Has a life expectancy of less than 3 months and/or has rapidly progressive disease
- •Has a diagnosed and/or treated additional malignancy within 5 years prior to allocation with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer
- •Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has a history of or current non-infectious pneumonitis/interstitial lung disease that requires steroids
- •Has an active infection requiring systemic therapy
- •Has a known history of human immunodeficiency virus (HIV) infection
- •Has a known history of Hepatitis B or Hepatitis C virus infection
- •Has had an allogenic tissue/solid organ transplant
研究组 & 干预措施
Pembrolizumab + Carboplatin + Paclitaxel
Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months).
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Carboplatin + Paclitaxel
Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months).
干预措施: Carboplatin (Drug)
Pembrolizumab + Carboplatin + Paclitaxel
Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months).
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to ~25 months
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.
次要结局
- Duration of Response (DOR)(Up to ~25 months)
- Progression-free Survival (PFS)(Up to ~25 months)
- Overall Survival (OS)(Up to ~25 months)
- Percentage of Participants Who Experienced an Adverse Event (AE)(Up to ~39 months)
- Percentage of Participants Who Discontinued Study Treatment Due to an AE(Up to ~25 months)