A Phase 3, Randomized, Multicenter, Double-blind Study of the Efficacy and Safety of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With HER2-negative, PD-L1-Positive Advanced or Metastatic Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
Participants will:
- Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy.
- Make visits to the clinic for checkups and tests.
- Answer questions about their health throughout the trial.
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
- •Have advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma that has been histologically confirmed to be predominant adenocarcinoma.
- •Have not been treated with systemic anticancer agents for advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
- •Participants who have received neoadjuvant or adjuvant therapy may be included if no residual tumors are found after surgery (R0 resection) and if the therapy was completed at least 180 days before the date of recurrence.
- •Have measurable or nonmeasurable disease, as defined in Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1, and documented on computed tomography (CT) or magnetic resonance imaging (MRI) images within 42 days before Cycle 1 Day 1 (C1D1).
- •Tumor programmed cell death ligand 1 (PD-L1) expression must be confirmed as combined positive score (CPS ≥1) prior to randomization.
- •Participant must be able to provide tissues samples for analyses.
排除标准
- •Participants with Human epidermal growth factor 2 (HER2)-positive or indeterminate gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma as determined by local testing. Determination for HER2 positivity is made based on the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry (IHC), or 2+ by IHC and positive by in situ hybridization.
- •Participants whose tumors have known microsatellite instability-high or mismatch repair-deficient status.
- •Marked malnutrition requiring continuous enteral nutrition or intravenous hyperalimentation, or continuous infusion therapy with hospitalization.
- •Active autoimmune disease, or history of autoimmune disease that might recur, that may affect vital organ function, or that may require immune-suppressive treatment, including systemic corticosteroids.
- •Participants with vitiligo, type 1 diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled.
- •Other protocol-defined inclusion and exclusion criteria apply.
研究组 & 干预措施
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: Levoleucovorin (Drug)
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: Tegafur-gimeracil-oteracil potassium (S-1) (Drug)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Placebo (Other)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Tegafur-gimeracil-oteracil potassium (S-1) (Drug)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Levoleucovorin (Drug)
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: Nivolumab (Drug)
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: Oxaliplatin (Drug)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Oxaliplatin (Drug)
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: Fluorouracil (Drug)
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: Leucovorin Calcium (Drug)
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: ONO-4578 (Drug)
ONO-4578 + Nivolumab + Chemotherapy
Participants will receive nivolumab and chemotherapy, which will include some of the listed agents.
干预措施: Capecitabine (Drug)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Fluorouracil (Drug)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Leucovorin Calcium (Drug)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Nivolumab (Drug)
Placebo + Nivolumab + Chemotherapy
Participants will receive placebo and chemotherapy, which will include some of the listed agents.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
时间窗: Up to approximately 4 years
Overall Survival (OS)
时间窗: Up to approximately 4 years
次要结局
- Objective Response Rate (ORR) per BICR(Up to approximately 4 years)
- Duration of Response (DOR) per BICR(Up to approximately 4 years)
- Disease Control Rate (DCR) per BICR(Up to approximately 4 years)
- PFS per Investigator Assessment(Up to approximately 4 years)
- Time to Response (TTR) per BICR(Up to approximately 4 years)
- PFS After the Next-line of Therapy (PFS2) per Investigator Assessment(Up to approximately 4 years)