NCT07221149招募中2 期
ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 690
- 试验地点
- 161
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
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
- •Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
- •Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study.
- •Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
- •Participants must have measurable disease as defined by RECIST v1.1.
排除标准
- •Participants must not have untreated known central nervous system (CNS) metastases.
- •Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- •Participants must not have evidence of major coagulation disorders (eg, hemophilia).
- •Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.
- •Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
- •Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm A1
Experimental
干预措施: Pumitamig (Drug)
Arm C
Experimental
干预措施: Pumitamig (Drug)
Arm A1
Experimental
干预措施: Folfox (Drug)
Arm A2
Experimental
干预措施: Pumitamig (Drug)
Arm A2
Experimental
干预措施: Folfox (Drug)
Arm A1
Experimental
干预措施: Capox (Drug)
Arm A2
Experimental
干预措施: Capox (Drug)
Arm C
Experimental
干预措施: Capox (Drug)
Arm D
Experimental
干预措施: Folfox (Drug)
Arm D
Experimental
干预措施: Capox (Drug)
Arm C
Experimental
干预措施: Folfox (Drug)
Arm D
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to approximately 47 months
Phase 3
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
时间窗: Up to 2 years after the last participant is randomized
Phase 2
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
时间窗: Up to approximately 33 months
Phase 3
次要结局
- PFS by RECIST v1.1 per investigator assessment(Up to approximately 33 months)
- Recommended dose of Pumitamig for Phase 3(Up to approximately 33 months)
- Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment(Up to approximately 33 months)
- Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment(Up to approximately 33 months)
- Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment(Up to approximately 33 months)
- Objective response (OR) by RECIST v1.1 per BICR(Up to approximately 33 months)
- DOR by RECIST v1.1 per BICR(Up to approximately 33 months)
研究者
研究点 (161)
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