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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 120
- 主要终点
- Phase 2: To compare what proportion of participants in the study drug arms and SOC arm responds to treatment (OR).
研究概览
简要总结
Phase 2: The main objective will be to compare the tumor response to treatment in participants on the study drug (pumitamig) in combination with chemotherapy vs bevacizumab in combination with chemotherapy, the standard of care (SOC). Phase 3: The main objectives are to compare the tumor growth of participants on the study drug vs the SOC and to see if participants live longer on the study drug compared to the SOC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 18 years of age.
- •Have colorectal cancer that has come back or spread and cannot be cured with surgery.
- •Have not had cancer treatment before.
- •Do not have a type of colorectal cancer known as dMMR/MSI-H.
- •Do not have a BRAF V600E gene mutation.
- •Have cancer that can be measured on a scan.
排除标准
- •Have cancer that has spread to the brain, spinal cord, or surrounding areas and has not been treated.
- •Had other active cancer in the past 2 years (except low-risk cases that have been cured locally).
- •Have serious heart problems, such as a recent heart attack, stroke, blocked arteries, uncontrolled high blood pressure, or certain genetic heart rhythm issues.
- •Have already had checkpoint inhibitors, CD137 agonists, or chemotherapy.
研究组 & 干预措施
OXALIPLATIN
干预措施: OXALIPLATIN (Drug)
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
干预措施: IRINOTECAN HYDROCHLORIDE TRIHYDRATE (Drug)
FLUOROURACIL
干预措施: FLUOROURACIL (Drug)
CALCIUM FOLINATE
干预措施: CALCIUM FOLINATE (Drug)
CAPECITABINE, CAPECITABINE
干预措施: CAPECITABINE (Drug)
BNT327 20 mg ml, BNT327 50 mg ml
干预措施: BNT327 50 mg ml (Drug)
BNT327 20 mg ml, BNT327 50 mg ml
干预措施: BNT327 20 mg ml (Drug)
BEVACIZUMAB
干预措施: BEVACIZUMAB (Drug)
结局指标
主要结局
Phase 2: To compare what proportion of participants in the study drug arms and SOC arm responds to treatment (OR).
Phase 2: To compare what proportion of participants in the study drug arms and SOC arm responds to treatment (OR).
Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS), and how long the patients live (OS)..
Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS), and how long the patients live (OS)..
Phase 2: To compare what proportion of participants in the study drug and standard of care arm respond to treatment (OR).
Phase 2: To compare what proportion of participants in the study drug and standard of care arm respond to treatment (OR).
Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS).
Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS).
次要结局
- Phase 2: To assess all available data including how effective, safe and tolerable the study drug is to arrive at a dose for Phase 3.
- Phase 3: To evaluate what proportion of participants in the study drug arm and SOC arm respond to treatment (OR) and how long the study drug effects on the tumor growth last after it is given (DOR).
- Phase 2: To assess all available data including how effective, safe and tolerable the study drug is to arrive at a dose.
- Phase 3: To evaluate how long patients live (OS) and how long the study drug effects on the tumor growth last after it is given (DOR).
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company