NCT07221357招募中2 期
ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
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
- 990
- 试验地点
- 285
- 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 bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
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
- •Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
- •Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
- •Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
- •Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
排除标准
- •Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
- •Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
- •Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- •Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm D
Other
干预措施: FOLFIRI (Drug)
Arm A1
Experimental
干预措施: Pumitamig (Drug)
Arm A2
Experimental
干预措施: FOLFOX (Drug)
Arm A1
Experimental
干预措施: FOLFOX (Drug)
Arm D
Other
干预措施: Bevacizumab (Drug)
Arm C
Experimental
干预措施: FOLFIRI (Drug)
Arm A2
Experimental
干预措施: FOLFIRI (Drug)
Arm B
Other
干预措施: Bevacizumab (Drug)
Arm D
Other
干预措施: FOLFOX (Drug)
Arm C
Experimental
干预措施: FOLFOX (Drug)
Arm D
Other
干预措施: CAPOX (Drug)
Arm A1
Experimental
干预措施: FOLFIRI (Drug)
Arm A2
Experimental
干预措施: Pumitamig (Drug)
Arm B
Other
干预措施: FOLFOX (Drug)
Arm B
Other
干预措施: FOLFIRI (Drug)
Arm C
Experimental
干预措施: Pumitamig (Drug)
Arm C
Experimental
干预措施: CAPOX (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 5 years
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 5 years
Phase 2
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
时间窗: Up to 5 years
Phase 3
次要结局
- PFS by RECIST v1.1 per investigator assessment(Up to 5 years)
- Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment(Up to 5 years)
- Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment(Up to 5 years)
- Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment(Up to 5 years)
- Recommended dose of Pumitamig for Phase 3(Up to 5 years)
- OR by RECIST v1.1 per BICR(Up to 5 years)
- DOR by RECIST v1.1 per BICR(Up to 5 years)
研究者
研究点 (285)
Loading locations...
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