Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 105
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit.
- •Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.
排除标准
- •Participant is not eligible for study treatment per the parent study eligibility criteria.
- •Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.
- •Participants not receiving clinical benefit from parent study drug as assessed by the investigator.
- •Other protocol defined inclusion/exclusion criteria applies.
研究组 & 干预措施
Arm B1
干预措施: Pembrolizumab (Drug)
Arm B2
干预措施: Pembrolizumab (Drug)
Arm B4
干预措施: Pemetrexed (Drug)
Arm C3
干预措施: Irinotecan (Drug)
Arm C4
干预措施: Leucovorin (Drug)
Arm C4
干预措施: Oxaliplatin (Drug)
Arm C4
干预措施: Fluorouracil (Drug)
Arm B4
干预措施: Adagrasib (Drug)
Arm B4
干预措施: Pembrolizumab (Drug)
Arm C1
干预措施: Pembrolizumab (Drug)
Arm C2
干预措施: Docetaxel (Drug)
Arm C3
干预措施: Leucovorin (Drug)
Arm A1
干预措施: Adagrasib (Drug)
Arm A2
干预措施: Adagrasib (Drug)
Arm B1
干预措施: Adagrasib (Drug)
Arm B3
干预措施: Cetuximab (Drug)
Arm B3
干预措施: Adagrasib (Drug)
Arm C3
干预措施: Fluorouracil (Drug)
Arm B2
干预措施: Adagrasib (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 90 days from last dose or study discontinuation
Number of Participants With AEs Leading to Treatment Discontinuation
时间窗: Up to 90 days from last dose or study discontinuation
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to 90 days from last dose or study discontinuation
Number of Participants With AEs Leading to Death
时间窗: Up to 90 days from last dose or study discontinuation
次要结局
未报告次要终点