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Trial record 1 of 1 for:    NCT03336216
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A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03336216
Recruitment Status : Active, not recruiting
First Posted : November 8, 2017
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE November 8, 2017
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
Progression free survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Progression-Free Survival (PFS) [ Time Frame: Up to 12 months ]
using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
  • Progression Free Survival (PFS) by Investigator Assessment [ Time Frame: Up to 12 months ]
  • Progression Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
  • Objective response rate (ORR) [ Time Frame: Up to 12 Months ]
  • Duration of response (DOR) [ Time Frame: Up to 12 Months ]
  • Overall Survival (OS) [ Time Frame: Up to 2 Years ]
  • Overall survival rate (OSR) [ Time Frame: Up to 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 Adverse Events (AE) leading to discontinuation [ Time Frame: Approximately 2 years ]
  • Incidence of death [ Time Frame: Approximately 2 years ]
  • Number of clinically significant changes in lab assessment: Blood [ Time Frame: Approximately 2 years ]
  • Number of clinically significant changes in lab assessment: Blood Serum [ Time Frame: Approximately 2 years ]
  • Number of clinically significant changes in lab assessment: Urine [ Time Frame: Approximately 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm A

    Investigator choice of chemotherapy:

    Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)

    Interventions:
    • Drug: Nab-paclitaxel
    • Drug: Onivyde
    • Drug: Fluorouracil
    • Drug: Gemcitabine
    • Drug: Leucovorin
    • Drug: Irinotecan Hydrochloride
  • Experimental: Arm B
    Cabiralizumab Q2W + Nivolumab Q4W
    Interventions:
    • Biological: Cabiralizumab
    • Biological: Nivolumab
  • Experimental: Arm C
    Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
    Interventions:
    • Biological: Cabiralizumab
    • Drug: Nab-paclitaxel
    • Biological: Nivolumab
    • Drug: Gemcitabine
  • Experimental: Arm D
    Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
    Interventions:
    • Biological: Cabiralizumab
    • Biological: Nivolumab
    • Drug: Fluorouracil
    • Drug: Oxaliplatin
    • Drug: Leucovorin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 19, 2020)
179
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
160
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Germany,   Italy,   Japan,   Korea, Republic of,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03336216
Other Study ID Numbers  ICMJE CA025-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date September 2020

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