A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
- Conditions
- Advanced Pancreatic Cancer
- Interventions
- Biological: CabiralizumabBiological: Nivolumab
- Registration Number
- NCT03336216
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm D Nivolumab Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W Arm C Nivolumab Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W Arm A Nab-paclitaxel Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) Arm D Cabiralizumab Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W Arm B Cabiralizumab Cabiralizumab Q2W + Nivolumab Q4W Arm B Nivolumab Cabiralizumab Q2W + Nivolumab Q4W Arm C Cabiralizumab Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W Arm C Nab-paclitaxel Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W Arm A Onivyde Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) Arm D Oxaliplatin Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W Arm A Fluorouracil Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) Arm A Gemcitabine Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) Arm A Leucovorin Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) Arm A Irinotecan Hydrochloride Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) Arm C Gemcitabine Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W Arm D Fluorouracil Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W Arm D Leucovorin Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) by BICR 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.
- Secondary Outcome Measures
Name Time Method 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) PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator 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.Overall Survival (OS) From randomization to the date of death to any cause (up to approximately 65 months) OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates.
Progression Free Survival Rate (PFSR) by BICR At 6, 9, and 12 months Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 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.Progression Free Survival Rate (PFSR) by Investigator At 6, 9, and 12 months Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator 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.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) An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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 treated participants who experienced a laboratory abnormality of the liver during the course of the study.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)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) The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN) Upper Limit of Normal (ULN)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) ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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.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) ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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.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) DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.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) A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
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) DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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.Overall Survival Rates (OSR) At 6 months, 1 year, and 2 years Overall survival at 6 months, 1 year, and 2 years is defined as the percentage of participants who are alive at 6 months, 1 year, and 2 years. Based on Kaplan-Meier Estimates.
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) An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
The Number of Participants Who Died From first dose to 150 days after last dose of study therapy (up to approximately 53 months) The number of participants that died during the study.
Trial Locations
- Locations (41)
Local Institution - 0006
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0007
🇺🇸Los Angeles, California, United States
Dana Farber Cancer Institute.
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Local Institution - 0011
🇺🇸Houston, Texas, United States
University Of Washington
🇺🇸Seattle, Washington, United States
Local Institution - 0022
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0009
🇺🇸Pittsburgh, Pennsylvania, United States
University Of Colorado
🇺🇸Aurora, Colorado, United States
Local Institution - 0010
🇺🇸Boston, Massachusetts, United States
Local Institution - 0001
🇺🇸Baltimore, Maryland, United States
Local Institution - 0012
🇺🇸New York, New York, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0005
🇺🇸New York, New York, United States
Tennessee Oncology Chattanooga
🇺🇸Nashville, Tennessee, United States
Local Institution - 0013
🇺🇸Dallas, Texas, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0041
🇩🇰Herlev, Denmark
Local Institution - 0037
🇨🇦Kingston, Ontario, Canada
Local Institution - 0035
🇨🇦Toronto, Ontario, Canada
Local Institution - 0032
🇩🇪Heidelberg, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Local Institution - 0029
🇩🇪Mannheim, Germany
Local Institution - 0030
🇩🇪Wuerzburg, Germany
Local Institution - 0025
🇮🇹Padova, Italy
Local Institution - 0026
🇮🇹Roma, Italy
Local Institution - 0021
🇪🇸Barcelona, Spain
Local Institution - 0017
🇰🇷Seoul, Korea, Republic of
Local Institution - 0020
🇪🇸Madrid, Spain
Local Institution - 0034
🇨🇭Lausanne, Switzerland
Local Institution - 0033
🇨🇭Chur, Switzerland
Local Institution - 0016
🇬🇧Glasgow, Lanarkshire, United Kingdom
Local Institution - 0024
🇨🇳Taipei City, Taiwan
Local Institution - 0031
🇨🇳Taipei, Taiwan
Local Institution - 0018
🇰🇷Seoul, Korea, Republic of
Local Institution - 0019
🇪🇸Madrid, Spain
Florida Cancer Specialists - North
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0023
🇯🇵Kashiwa-shi, Chiba, Japan
Florida Cancer Specialists - South
🇺🇸Fort Myers, Florida, United States
Mayo Clinic in Rochester, Minnesota
🇺🇸Phoenix, Arizona, United States
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States