A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS- 986205, Followed by Continued Post- Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 386
- 试验地点
- 59
- 主要终点
- Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone
研究概览
简要总结
To compare the pCR rate of neoadjuvant nivolumab + GC to neoadjuvant GC alone in all randomized participants (Arm B vs. Arm A).
To compare EFS of neoadjuvant nivolumab + GC followed by continued nivolumab after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm B vs. Arm A).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if there is a predominant urothelial component.
- •Participant must be deemed eligible for RC by his/her oncologist and/or urologist, and must agree to undergo RC after completion of neoadjuvant therapy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
排除标准
- •Clinical evidence of positive LN (≥ 10 mm in short axis) or metastatic bladder cancer
- •Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is also not permitted
- •Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured (24-hour urine) creatinine clearance (CrCl) < 50 mL/min
结局指标
主要结局
Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone
Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone
Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo
Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo
Event-Free Survival (EFS) of SOC Chemo after RC
Event-Free Survival (EFS) of SOC Chemo after RC
Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC
Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC
次要结局
- pCR rate, EFS, and OS as defined
- Incidence of Adverse Events (AE)
- Incidence of Serious Adverse Events (SAE)
- Incidence of Laboratory abnormalities
- Overall Survival (OS)
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation