A Randomized, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 470
- 试验地点
- 535
- 主要终点
- Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Navlimetostat (BMS-986504), a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
- •Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue.
- •Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1).
- •Participants must not have received any systemic anticancer treatments in the metastatic setting.
- •If clinically indicated and as per investigator discretion, participants may receive up to 1 cycle of Nab-paclitaxel/Gemcitabine (nab-p/gem) in the metastatic setting and must have not progressed or required discontinuation due to intolerable toxicity.
- •Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization.
排除标准
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm E
干预措施: Nab-paclitaxel (Drug)
Arm F
干预措施: Nab-paclitaxel (Drug)
Arm F
干预措施: Placebo (Drug)
Arm C
干预措施: Gemcitabine (Drug)
Arm C
干预措施: Nab-paclitaxel (Drug)
Arm B
干预措施: Nab-paclitaxel (Drug)
Arm B
干预措施: Gemcitabine (Drug)
Arm D
干预措施: Gemcitabine (Drug)
Arm A
干预措施: Gemcitabine (Drug)
Arm A
干预措施: Nab-paclitaxel (Drug)
Arm C
干预措施: Placebo (Drug)
Arm D
干预措施: Placebo (Drug)
Arm B
干预措施: Navlimetostat (Drug)
Arm A
干预措施: Navlimetostat (Drug)
Arm E
干预措施: Navlimetostat (Drug)
Arm D
干预措施: Nab-paclitaxel (Drug)
Arm E
干预措施: Gemcitabine (Drug)
Arm F
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)
时间窗: Up to 3 years after last participant is randomized
Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)
Overall Survival (OS)
时间窗: Up to 3 years after last participant is randomized
Defined as the time from the randomization date to the date of death from any cause
Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)
时间窗: Up to 3 years after last participant is randomized
Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)
Overall Survival (OS)
时间窗: Up to 3 years after last participant is randomized
Defined as the time from the randomization date to the date of death from any cause
次要结局
- Objective Response (OR) as assessed by RECIST v1.1(Up to 3 years after last participant is randomized)
- Duration of Response (DOR) as assessed by RECIST v1.1(Up to 3 years after last participant is randomized)
- Time to Objective Response (TTOR) as assessed by RECIST v1.1(Up to 3 years after last participant is randomized)
- Disease control as assessed by RECIST v1.1(Up to 3 years after last participant is randomized)
- PFS as assessed by RECIST v1.1(Up to 3 years after last participant is randomized)
- Number of participants with treatment-related adverse events (TRAEs)(Up to 28 days after the last drug administration)
- Number of participants with all-cause treatment-emergent adverse events (TEAEs)(Up to 28 days after the last drug administration)
- Number of participants with treatment-emergent serious adverse events (TESAEs)(Up to 28 days after the last drug administration)
- Number of participants with TEAEs leading to dose interruption, reduction, or discontinuation(Up to 28 days after the last drug administration)
- Number of participants with laboratory abnormalities(Up to 28 days after the last drug administration)