A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 840
- 试验地点
- 74
- 主要终点
- Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator
研究概览
简要总结
This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.
To join the study, participants must meet the following conditions:
Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.
The study has two parts:
- In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.
- In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.
The treatment will be given in repeated time periods called cycles.
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)
盲法说明
Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design
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
- •Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.
- •Evidence of locally advanced or metastatic disease.
- •Eastern Cooperative Oncology Group performance status (ECOG) 0-1
- •No prior systemic therapy for advanced or metastatic disease.
- •Adequate hepatic, liver, and renal function
- •HER-2 negative status based on local testing
- •PD-L1 positive status based on local testing
排除标准
- •Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression
- •Clinically significant risk of hemorrhage or fistula
- •Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
- •Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
- •Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
- •Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
研究组 & 干预措施
Phase 2 Portion
PF-08634404 + Chemotherapy
干预措施: PF-08634404 (Biological)
Phase 2 Portion
PF-08634404 + Chemotherapy
干预措施: Chemotherapy (Drug)
Phase 3: Arm A
PF-08634404 + Chemotherapy
干预措施: PF-08634404 (Biological)
Phase 3: Arm B
Nivolumab + Chemotherapy
干预措施: Chemotherapy (Drug)
Phase 3: Arm A
PF-08634404 + Chemotherapy
干预措施: Chemotherapy (Drug)
Phase 3: Arm B
Nivolumab + Chemotherapy
干预措施: Nivolumab (Biological)
结局指标
主要结局
Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator
时间窗: Approximately 4 years
Confirmed ORR by investigator is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator.
Phase 2: Number of participants with treatment-emergent adverse events
时间窗: Through 90 days after the last study intervention; Approximately 4 years
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR
时间窗: Approximately 4 years
PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurs first.
Phase 3: Overall Survival (OS)
时间窗: Approximately 4 years
OS is defined as the time from the date of randomization to the date of death due to any cause.
次要结局
- Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator(Approximately 4 years)
- Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator(Approximately 4 years)
- Phase 2: Overall Survival (OS)(Approximately 4 years)
- Phase 2: Number of participants with laboratory abnormalities(Through 90 days after the last study intervention; Approximately 4 years)
- Phase 2: Serum concentrations of PF-08634404(Approximately 21 months)
- Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404(Approximately 21 months)
- Phase 3: ORR using RECIST 1.1 as assessed by BICR(Approximately 4 years)
- Phase 3: ORR using RECIST 1.1 as assessed by investigator(Approximately 4 years)
- Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator(Approximately 4 years)
- Phase 3: DOR using RECIST 1.1 as assessed by BICR(Approximately 4 years)
- Phase 3: Change from baseline in Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Total score(Approximately 4 years)
- Phase 3: DOR using RECIST 1.1 as assessed by investigator(Approximately 4 years)
- Phase 3: PFS2 (PFS after next-line therapy) by investigator(Approximately 4 years)
- Phase 3: Number of participants with treatment-emergent adverse events(Through 90 days after the last study intervention; Approximately 4 years)
- Phase 3: Number of participants with laboratory abnormalities(Through 90 days after the last study intervention; Approximately 4 years)
- Phase 3: Time to definitive deterioration in FACT-Ga Total score(Approximately 4 years)
- Phase 3: Serum concentrations of PF-08634404(Approximately 21 months)
- Phase 3: Incidence of ADA against PF-08634404(Approximately 21 months)
- Phase 3: Time to definitive deterioration in Gastric Cancer Subscale (GaCS) score(Approximately 4 years)