A Phase 2 Open-Label Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Pembrolizumab as First-Line Treatment in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 20
- 主要终点
- Number of Participants with Adverse Events (AE)s
研究概览
简要总结
Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide with an annual incidence of approximately 700,000 cases. This study aims to evaluate the change in disease activity and optimal dose, and optimal dose of telisotuzumab adizutecan in combination with pembrolizumab as first-line treatment in participants with recurrent or metastatic head and neck squamous cell carcinoma.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of recurrent or metastatic HNSCC. Participants are placed into 3 treatment groups called treatment arms. Each group receives a different treatment. Adult participants diagnosed with recurrent or metastatic HNSCC who have not received prior systemic therapy for advanced disease and whose tumors express c-Met protein will be enrolled. Approximately 180 participants will be enrolled in the study at sites worldwide.
Participants will receive intravenous doses of telisotuzumab adizutecan with intravenous pembrolizumab, or standard of care (SOC) chemotherapy with pembrolizumab. Participants will receive treatment as part of a 38 month study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits every 3 weeks during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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
- 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 or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable by local therapies.
- •Eastern cooperative oncology group (ECOG) performance status must be <=
- •Must have c-Met protein expression by central c-Met immunohistochemistry (IHC) staining at any intensity in >= 25% tumor cells.
- •Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.
- •Must have had no prior systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
排除标准
- •Have history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis on screening chest computed tomography (CT) scan.
- •Have any major, life-threatening conditions.
- •Life expectancy should be at least 3 months.
研究组 & 干预措施
Pembrolizumab + Platinum Chemotherapy + Fluorouracil
Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 38 month study duration.
干预措施: Fluorouracil (Drug)
Pembrolizumab + Platinum Chemotherapy + Fluorouracil
Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 38 month study duration.
干预措施: Carboplatin (Drug)
Telisotuzumab Adizutecan Dose A + Pembrolizumab
Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 38 month study duration.
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Platinum Chemotherapy + Fluorouracil
Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 38 month study duration.
干预措施: Cisplatin (Drug)
Pembrolizumab + Platinum Chemotherapy + Fluorouracil
Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 38 month study duration.
干预措施: Pembrolizumab (Drug)
Telisotuzumab Adizutecan Dose B + Pembrolizumab
Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 38 month study duration.
干预措施: Pembrolizumab (Drug)
Telisotuzumab Adizutecan Dose A + Pembrolizumab
Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 38 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
Telisotuzumab Adizutecan Dose B + Pembrolizumab
Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 38 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AE)s
时间窗: Up to Approximately 38 Months
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Objective Response (OR) Rate Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
时间窗: Up to Approximately 38 Months
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Progression-Free Survival (PFS) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
时间窗: Up to Approximately 38 Months
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
次要结局
- Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to Approximately 38 Months)
- Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to Approximately 38 Months)
- OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to Approximately 38 Months)
- PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to Approximately 38 Months)
- DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to Approximately 38 Months)
- DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1(Up to Approximately 38 Months)
- Overall Survival (OS)(Up to Approximately 38 Months)