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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03336216
Collaborator
(none)
262
Enrollment
41
Locations
4
Arms
61.9
Anticipated Duration (Months)
6.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
262 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 19, 2017
Anticipated Primary Completion Date :
Aug 12, 2022
Anticipated Study Completion Date :
Feb 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A

Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)

Drug: Nab-paclitaxel
specified does on specified days
Other Names:
  • Abraxane

    • Drug: Onivyde
    specified dose on specified days
    Other Names:
  • irinotecan liposome

    • Drug: Fluorouracil
    specified dose on specified days
    Other Names:
  • 5-Fluorouracil

    • Drug: Gemcitabine
    specified dose on specified days

    Drug: Leucovorin
    Specified dose on specified days

    Drug: Irinotecan Hydrochloride
    Specified dose on specified days
    Experimental: Arm B

    Cabiralizumab Q2W + Nivolumab Q4W

    Biological: Cabiralizumab
    specified dose on specified days
    Other Names:
  • BMS-986227, FPA008

    • Biological: Nivolumab
    specified dose on specified days
    Other Names:
  • Opdivo, BMS-936558

    		•
    Experimental: Arm C

    Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W

    Biological: Cabiralizumab
    specified dose on specified days
    Other Names:
  • BMS-986227, FPA008

    • Drug: Nab-paclitaxel
    specified does on specified days
    Other Names:
  • Abraxane

    • Biological: Nivolumab
    specified dose on specified days
    Other Names:
  • Opdivo, BMS-936558

    • Drug: Gemcitabine
    specified dose on specified days
    Experimental: Arm D

    Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W

    Biological: Cabiralizumab
    specified dose on specified days
    Other Names:
  • BMS-986227, FPA008

    • Biological: Nivolumab
    specified dose on specified days
    Other Names:
  • Opdivo, BMS-936558

    • Drug: Fluorouracil
    specified dose on specified days
    Other Names:
  • 5-Fluorouracil

    • Drug: Oxaliplatin
    specified dose on specified day

    Drug: Leucovorin
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) by Blinded Independent Central Review (BICR) [Up to 12 months]

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) by Investigator Assessment [Up to 12 months]

    2. Progression Free Survival Rate (PFSR) [Up to 12 months]

    3. Objective response rate (ORR) [Up to 12 Months]

    4. Duration of response (DOR) [Up to 12 Months]

    5. Overall Survival (OS) [Up to 2 Years]

    6. Overall survival rate (OSR) [Up to 2 years]

    7. Incidence of Adverse Events (AE) [Approximately 2 years]

    8. Incidence of Serious Adverse Events (SAE) [Approximately 2 years]

    9. Incidence of Adverse Events (AE) leading to discontinuation [Approximately 2 years]

    10. Incidence of death [Approximately 2 years]

    11. Number of clinically significant changes in lab assessment: Blood [Approximately 2 years]

    12. Number of clinically significant changes in lab assessment: Blood Serum [Approximately 2 years]

    13. Number of clinically significant changes in lab assessment: Urine [Approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic - PPDS Phoenix Arizona United States 85054
    2 HonorHealth Research Institute Scottsdale Arizona United States 85258
    3 Ucla Medical Center Los Angeles California United States 90095
    4 University Of Colorado Aurora Colorado United States 80045
    5 Florida Cancer Specialists - South Fort Myers Florida United States 33901
    6 Florida Cancer Specialists - North Saint Petersburg Florida United States 33705
    7 Johns Hopkins University Baltimore Maryland United States 21287
    8 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02114
    9 Dana Farber Cancer Institute. Boston Massachusetts United States 02114
    10 Massachusetts General Hospital Boston Massachusetts United States 02114
    11 Washington University Saint Louis Missouri United States 63110
    12 Laura & Isaac Perlmutter Cancer Ctr at NYU Langone New York New York United States 10016
    13 Memorial Sloan Kettering Nassau New York New York United States 10065
    14 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    15 UPMC Pittsburgh Pennsylvania United States 15232
    16 Tennessee Oncology, PLLC - SCRI - PPDS Nashville Tennessee United States 37203
    17 Ut Southwestern Medical Center Dallas Texas United States 75235
    18 Md Anderson Houston Texas United States 77030
    19 University of Washington Seattle Washington United States 98109
    20 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    21 Local Institution Kingston Ontario Canada K7L 2V7
    22 Local Institution Toronto Ontario Canada M5G 2M9
    23 Local Institution Herlev Denmark 2730
    24 Universitaetsklinik Heidelberg Heidelberg Germany 69120
    25 Universitatsmedizin Mannheim Mannheim Germany 68167
    26 Universitaetsklinikum Ulm Ulm Germany 89081
    27 Univ. Klinikum Wuerzburg Wuerzburg Germany 97080
    28 I.O.V. Istituto Oncologico Veneto Ircss Padova Italy Padova
    29 Policlinico Gemelli Rome Italy 00168
    30 Local Institution Kashiwa-shi Chiba Japan 2778577
    31 Local Institution Chuo-ku Tokyo Japan 1040045
    32 Local Institution Seoul Korea, Republic of 03080
    33 Local Institution Seoul Korea, Republic of 06351
    34 H. Univ. Vall dHebron Barcelona Spain 08035
    35 Hospital Gral. Univ. Gregorio Maranon Madrid Spain 28007
    36 Hosp Univer 12 De Octubre Madrid Spain 28041
    37 Kantonsspital Graubuenden Chur Switzerland 7000
    38 Centre hospitalier universitaire Vaudois (CHUV) Lausanne Switzerland 1011
    39 Local Institution Taipei Taiwan 10002
    40 Local Institution Taipei Taiwan 11217
    41 Local Institution Glasgow United Kingdom G12 0YN

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03336216
    Other Study ID Numbers:
    • CA025-006
    First Posted:
    Nov 8, 2017
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Leucovorin
    Gemcitabine
    Paclitaxel
    Fluorouracil
    Oxaliplatin
    Nivolumab
    Irinotecan

    Study Results

    No Results Posted as of Apr 7, 2022