Clinical trial NCT03336216: A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Pancreatic Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-11-08
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression Free Survival (PFS) by BICR
timeFrame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Secondary outcomes:
measure: Progression Free Survival (PFS) by Investigator
timeFrame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
measure: Progression Free Survival Rate (PFSR) by BICR
timeFrame: At 6, 9, and 12 months
measure: Progression Free Survival Rate (PFSR) by Investigator
timeFrame: At 6, 9, and 12 months
measure: Objective Response Rate (ORR) by BICR
timeFrame: 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)
measure: Objective Response Rate (ORR) by Investigator
timeFrame: 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)
measure: Duration of Response (DOR) by BICR
timeFrame: From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
measure: Duration of Response (DOR) by Investigator
timeFrame: From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death to any cause (up to approximately 65 months)
measure: Overall Survival Rates (OSR)
timeFrame: At 6 months, 1 year, and 2 years
measure: The Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
measure: The Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
measure: The Number of Participants With Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
measure: The Number of Participants Who Died
timeFrame: From first dose to 150 days after last dose of study therapy (up to approximately 53 months)
measure: The Number of Participants Who Experienced Abnormal Hepatic Tests
timeFrame: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
measure: The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0007
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Baltimore
country: United States
facility: Local Institution - 0001
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute.
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0010
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Local Institution - 0012
state: New York
city: New York
country: United States
facility: Local Institution - 0005
state: New York
city: Philadelphia
country: United States
facility: Local Institution - 0006
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0009
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology Chattanooga
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0013
state: Texas
city: Houston
country: United States
facility: Local Institution - 0011
state: Texas
city: Seattle
country: United States
facility: University Of Washington
state: Washington
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kingston
country: Canada
facility: Local Institution - 0037
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0035
state: Ontario
city: Herlev
country: Denmark
facility: Local Institution - 0041
city: Heidelberg
country: Germany
facility: Local Institution - 0032
city: Mannheim
country: Germany
facility: Local Institution - 0029
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Wuerzburg
country: Germany
facility: Local Institution - 0030
city: Padova
country: Italy
facility: Local Institution - 0025
city: Roma
country: Italy
facility: Local Institution - 0026
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0023
state: Chiba
city: Chuo-ku
country: Japan
facility: Local Institution - 0022
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0018
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0017
city: Barcelona
country: Spain
facility: Local Institution - 0021
city: Madrid
country: Spain
facility: Local Institution - 0019
city: Madrid
country: Spain
facility: Local Institution - 0020
city: Chur
country: Switzerland
facility: Local Institution - 0033
city: Lausanne
country: Switzerland
facility: Local Institution - 0034
city: Taipei City
country: Taiwan
facility: Local Institution - 0024
city: Taipei
country: Taiwan
facility: Local Institution - 0031
city: Glasgow
country: United Kingdom
facility: Local Institution - 0016
state: Lanarkshire
Study officials:
References: