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

This study is not yet open for participant recruitment.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT03336216
First Posted: November 8, 2017
Last Update Posted: November 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Advanced Pancreatic Cancer Biological: Cabiralizumab Drug: Nab-paclitaxel Drug: Onivyde Biological: Nivolumab Drug: Fluorouracil Drug: Gemcitabine Drug: Oxaliplatin Drug: Leucovorin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Up to 12 months ]
    using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: March 1, 2020
Estimated Primary Completion Date: March 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Investigator choice of chemotherapy either gemcitabine/nabpaclitaxel or 5-fluorouracil/leucovorin/irinotecan liposome
Drug: Nab-paclitaxel
specified does on specified days
Other Name: Abraxane
Drug: Onivyde
specified dose on specified days
Other Name: irinotecan liposome
Drug: Fluorouracil
specified dose on specified days
Other Name: 5-Fluorouracil
Drug: Gemcitabine
specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Experimental: Arm B
Cabiralizumab and Nivolumab
Biological: Cabiralizumab
specified dose on specified days
Other Name: BMS-986227, FPA008
Biological: Nivolumab
specified dose on specified days
Other Name: Opdivo, BMS-936558
Experimental: Arm C
cabiralizumab and nivolumab in combination with gemcitabine and abraxane
Biological: Cabiralizumab
specified dose on specified days
Other Name: BMS-986227, FPA008
Drug: Nab-paclitaxel
specified does on specified days
Other Name: Abraxane
Biological: Nivolumab
specified dose on specified days
Other Name: Opdivo, BMS-936558
Drug: Gemcitabine
specified dose on specified days
Experimental: Arm D
cabiralizumab and nivolumab in combination with oxaliplatin/5-Fluorouracil/leucovorin
Biological: Cabiralizumab
specified dose on specified days
Other Name: BMS-986227, FPA008
Biological: Nivolumab
specified dose on specified days
Other Name: Opdivo, BMS-936558
Drug: Fluorouracil
specified dose on specified days
Other Name: 5-Fluorouracil
Drug: Oxaliplatin
specified dose on specified day
Drug: Leucovorin
Specified dose on specified days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed during or after at least one line of systemic chemotherapy
  • ECOG Performance status 0-1
  • Adequate organ functions
  • Measurable disease

Exclusion Criteria:

  • Suspected, known, or progressive CNS metastases
  • Participants with active, known, or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease
  • Prior exposure to prior therapy with immune cell-modulating antibody regimens
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336216


Contacts
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 #.

Locations
United States, Arizona
HonorHealth Not yet recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN RN AOCNS         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Susan Sartorius-Mergenthaler    410-614-3644    Sartosu@jhmi.edu   
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Eileen M. O'Reilly    646-888-4182    oreillye@MSKCC.ORG   
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03336216     History of Changes
Other Study ID Numbers: CA025-006
First Submitted: November 6, 2017
First Posted: November 8, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Irinotecan
Oxaliplatin
Nivolumab
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors