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A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03336216
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

November 6, 2017
November 8, 2017
July 24, 2018
December 15, 2017
December 14, 2020   (Final data collection date for primary outcome measure)
Median progression free survival (mPFS) [ Time Frame: Up to 12 months ]
using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Progression-Free Survival (PFS) [ Time Frame: Up to 12 months ]
using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Complete list of historical versions of study NCT03336216 on ClinicalTrials.gov Archive Site
  • Trough observed serum concentration (Ctrough) [ Time Frame: Approximately 2 years ]
    summary of PK parameters
  • Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
    assessed per RECIST v1.1
  • Median duration of response (MDOR) [ Time Frame: Approximately 2 years ]
    assessed per RECIST v1.1
  • Overall survival rate (OSR) [ Time Frame: Approximately 2 years ]
  • Incidence of Adverse Events (AE) [ Time Frame: Approximately 2 years ]
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: Approximately 2 years ]
  • Incidence of death [ Time Frame: Approximately 2 years ]
  • Incidence of laboratory abnormalities [ Time Frame: Approximately 2 years ]
  • Incidence of Adverse Events (AE) leading to discontinuation [ Time Frame: Approximately 2 years ]
Same as current
Not Provided
Not Provided
 
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Pancreatic Cancer
  • Biological: Cabiralizumab
    specified dose on specified days
    Other Name: BMS-986227, FPA008
  • Drug: Nab-paclitaxel
    specified does on specified days
    Other Name: Abraxane
  • Drug: Onivyde
    specified dose on specified days
    Other Name: irinotecan liposome
  • Biological: Nivolumab
    specified dose on specified days
    Other Name: Opdivo, BMS-936558
  • Drug: Fluorouracil
    specified dose on specified days
    Other Name: 5-Fluorouracil
  • Drug: Gemcitabine
    specified dose on specified days
  • Drug: Oxaliplatin
    specified dose on specified day
  • Drug: Leucovorin
    Specified dose on specified days
  • Drug: Irinotecan Hydrochloride
    Specified dose on specified days
  • Active Comparator: Arm A

    Investigator choice of chemotherapy either gemcitabine/nabpaclitaxel (ABRAXANE) or 5-fluorouracil/leucovorin/irinotecan Liposome (ONIVYDE)

    ONIVYDE-based regimen can be substituted with FOLFIRI (leucovorin, fluorouracil, irinotecan hydrochloride)

    Interventions:
    • Drug: Nab-paclitaxel
    • Drug: Onivyde
    • Drug: Fluorouracil
    • Drug: Gemcitabine
    • Drug: Leucovorin
    • Drug: Irinotecan Hydrochloride
  • Experimental: Arm B
    Cabiralizumab and Nivolumab
    Interventions:
    • Biological: Cabiralizumab
    • Biological: Nivolumab
  • Experimental: Arm C
    cabiralizumab and nivolumab in combination with gemcitabine and abraxane
    Interventions:
    • Biological: Cabiralizumab
    • Drug: Nab-paclitaxel
    • Biological: Nivolumab
    • Drug: Gemcitabine
  • Experimental: Arm D
    cabiralizumab and nivolumab in combination with oxaliplatin/5-Fluorouracil/leucovorin
    Interventions:
    • Biological: Cabiralizumab
    • Biological: Nivolumab
    • Drug: Fluorouracil
    • Drug: Oxaliplatin
    • Drug: Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
Same as current
December 15, 2020
December 14, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Japan,   Spain,   Taiwan,   United States
 
 
NCT03336216
CA025-006
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP