Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 399
- 主要终点
- Incidence of Select AEs
研究概览
简要总结
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Signed Written Informed Consent.
- •Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
- •On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
- •WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.
排除标准
- •Participant is not eligible for study treatment per the Parent Study eligibility criteria.
- •Participants not receiving clinical benefit as assessed by the Investigator.
- •Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.
- •Other protocol-defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
E5: Enzalutamide Monotherapy
干预措施: Enzalutamide (Drug)
B1: Nivolumab + Ipilimumab
干预措施: Nivolumab (Drug)
B3: Nivolumab + Ipilimumab + Trametinib
干预措施: Trametinib (Drug)
B3: Nivolumab + Ipilimumab + Trametinib
干预措施: Ipilimumab (Drug)
C6: Relatlimab + Nivolumab + Capecitabine
干预措施: Nivolumab + Relatlimab (Drug)
E2: Regorafinib Monotherapy
干预措施: Regorafinib (Drug)
E8: Capecitabine Monotherapy
干预措施: Capecitabine (Drug)
C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2
干预措施: Nivolumab + Relatlimab (Drug)
C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1
干预措施: Nivolumab (Drug)
C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1
干预措施: Nivolumab + Relatlimab (Drug)
C11: Relatlimab + Nivolumab SAV + PDCT Dose 2
干预措施: Relatlimab (Drug)
D1: Nivolumab + Temozolomide
干预措施: Nivolumab (Drug)
D3: Nivolumab + Daratumumab
干预措施: Nivolumab (Drug)
E4: Leucovorin + Oxaliplatin + Fluorouracil
干预措施: Leucovorin (Drug)
E4: Leucovorin + Oxaliplatin + Fluorouracil
干预措施: Fluorouracil (Drug)
E7: Rucaparib Monotherapy
干预措施: Rucaparib (Drug)
B2: Nivolumab + Ipilimumab + Cabozantinib
干预措施: Nivolumab (Drug)
B2: Nivolumab + Ipilimumab + Cabozantinib
干预措施: Ipilimumab (Drug)
A1: Nivolumab Monotherapy Dose 1
干预措施: Nivolumab (Drug)
C6: Relatlimab + Nivolumab + Capecitabine
干预措施: Capecitabine (Drug)
A2: Nivolumab Monotherapy Dose 2
干预措施: Nivolumab (Drug)
B1: Nivolumab + Ipilimumab
干预措施: Ipilimumab (Drug)
C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1
干预措施: Relatlimab (Drug)
B2: Nivolumab + Ipilimumab + Cabozantinib
干预措施: Cabozantinib (Drug)
B3: Nivolumab + Ipilimumab + Trametinib
干预措施: Nivolumab (Drug)
C5: Relatlimab + Nivolumab + Ipilimumab
干预措施: Ipilimumab (Drug)
C4: Relatlimab + Nivolumab SAV Dose 2
干预措施: Nivolumab (Drug)
C4: Relatlimab + Nivolumab SAV Dose 2
干预措施: Relatlimab (Drug)
C5: Relatlimab + Nivolumab + Ipilimumab
干预措施: Nivolumab (Drug)
C7: Relatlimab + Nivolumab SAV Dose 3
干预措施: Relatlimab (Drug)
C7: Relatlimab + Nivolumab SAV Dose 3
干预措施: Nivolumab (Drug)
C10: Relatlimab + Nivolumab SAV Dose 4
干预措施: Nivolumab (Drug)
C12: Relatlimab + Nivolumab SAV Dose 5
干预措施: Nivolumab (Drug)
C10: Relatlimab + Nivolumab SAV Dose 4
干预措施: Relatlimab (Drug)
C12: Relatlimab + Nivolumab SAV Dose 5
干预措施: Relatlimab (Drug)
D2: Nivolumab + Rucaparib
干预措施: Nivolumab (Drug)
C9: Relatlimab + Nivolumab SAV + Bevacizumab
干预措施: Nivolumab (Drug)
C9: Relatlimab + Nivolumab SAV + Bevacizumab
干预措施: Relatlimab (Drug)
C8: Relatlimab + Nivolumab SAV + PDCT Dose 1
干预措施: Nivolumab (Drug)
C8: Relatlimab + Nivolumab SAV + PDCT Dose 1
干预措施: Relatlimab (Drug)
C11: Relatlimab + Nivolumab SAV + PDCT Dose 2
干预措施: Nivolumab (Drug)
C9: Relatlimab + Nivolumab SAV + Bevacizumab
干预措施: Bevacizumab (Drug)
D1: Nivolumab + Temozolomide
干预措施: Temozolomide (Drug)
D2: Nivolumab + Rucaparib
干预措施: Rucaparib (Drug)
D3: Nivolumab + Daratumumab
干预措施: Daratumumab (Drug)
D4: Nivolumab + Bevacizumab
干预措施: Nivolumab (Drug)
E1: Bevacizumab Monotherapy
干预措施: Bevacizumab (Drug)
E4: Leucovorin + Oxaliplatin + Fluorouracil
干预措施: Oxaliplatin (Drug)
E3: Leucovorin + Fluorouracil
干预措施: Leucovorin (Drug)
E6: Sunitinib Monotherapy
干预措施: Sunitinib (Drug)
E9: Cabozantinib Monotherapy
干预措施: Cabozantinib (Drug)
E10: Pemetrexed Monotherapy
干预措施: Pemetrexed (Drug)
E11: Pembrolizumab Monotherapy
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Incidence of Select AEs
时间窗: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Immune-Mediated AEs
时间窗: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Adverse Events (AEs)
时间窗: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of AEs leading to Discontinuation
时间窗: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Serious Adverse Events (SAEs)
时间窗: From signature of Informed Consent up to 135 Days after discontinuation of treatment
Incidence of Death
时间窗: From signature of Informed Consent up to 135 Days after discontinuation of treatment
Incidence of drug related AEs
时间窗: From Day 1 up to 135 Days after discontinuation of treatment
次要结局
未报告次要终点