A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 41
- 主要终点
- Progression Free Survival (PFS) by BICR
研究概览
简要总结
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
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
- 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
- •Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy
- •ECOG Performance status 0-1
- •Adequate organ functions
- •Measurable disease
排除标准
- •Suspected or known CNS metastasis
- •Participants with active, known, or suspected autoimmune disease
- •Uncontrolled or significant cardiovascular disease
- •Prior exposure to selected immune cell-modulating antibody regimens
研究组 & 干预措施
Arm A
Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
干预措施: Nab-paclitaxel (Drug)
Arm A
Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
干预措施: Onivyde (Drug)
Arm A
Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
干预措施: Fluorouracil (Drug)
Arm A
Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
干预措施: Gemcitabine (Drug)
Arm A
Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
干预措施: Leucovorin (Drug)
Arm A
Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
干预措施: Irinotecan Hydrochloride (Drug)
Arm B
Cabiralizumab Q2W + Nivolumab Q4W
干预措施: Cabiralizumab (Biological)
Arm B
Cabiralizumab Q2W + Nivolumab Q4W
干预措施: Nivolumab (Biological)
Arm C
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
干预措施: Cabiralizumab (Biological)
Arm C
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
干预措施: Nab-paclitaxel (Drug)
Arm C
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
干预措施: Nivolumab (Biological)
Arm C
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
干预措施: Gemcitabine (Drug)
Arm D
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
干预措施: Cabiralizumab (Biological)
Arm D
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
干预措施: Nivolumab (Biological)
Arm D
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
干预措施: Fluorouracil (Drug)
Arm D
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
干预措施: Oxaliplatin (Drug)
Arm D
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
干预措施: Leucovorin (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by BICR
时间窗: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
次要结局
- Progression Free Survival (PFS) by Investigator(From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months))
- Overall Survival (OS)(From randomization to the date of death to any cause (up to approximately 65 months))
- Progression Free Survival Rate (PFSR) by BICR(At 6, 9, and 12 months)
- Progression Free Survival Rate (PFSR) by Investigator(At 6, 9, and 12 months)
- The Number of Participants With Adverse Events (AEs) Leading to Discontinuation(From first dose to 100 days after last dose of study therapy (up to approximately 51 months))
- The Number of Participants Who Experienced Abnormal Hepatic Tests(From first dose and 100 days after last dose of study therapy (up to approximately 51 months))
- The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests(From first dose and 100 days after last dose of study therapy (up to approximately 51 months))
- Objective Response Rate (ORR) by BICR(From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months))
- Objective Response Rate (ORR) by Investigator(From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months))
- Duration of Response (DOR) by BICR(From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months))
- The Number of Participants With Serious Adverse Events (SAEs)(From first dose to 100 days after last dose of study therapy (up to approximately 51 months))
- Duration of Response (DOR) by Investigator(From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months))
- Overall Survival Rates (OSR)(At 6 months, 1 year, and 2 years)
- The Number of Participants With Adverse Events (AEs)(From first dose to 100 days after last dose of study therapy (up to approximately 51 months))
- The Number of Participants Who Died(From first dose to 150 days after last dose of study therapy (up to approximately 53 months))