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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 : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Advanced Pancreatic Cancer Biological: Cabiralizumab Drug: Nab-paclitaxel Drug: Onivyde Biological: Nivolumab Drug: Fluorouracil Drug: Gemcitabine Drug: Oxaliplatin Drug: Leucovorin Drug: Irinotecan Hydrochloride Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : December 15, 2017
Estimated Primary Completion Date : December 14, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
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)

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

Drug: Irinotecan Hydrochloride
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




Primary Outcome Measures :
  1. Median progression free survival (mPFS) [ Time Frame: Up to 12 months ]
    using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)


Secondary Outcome Measures :
  1. Trough observed serum concentration (Ctrough) [ Time Frame: Approximately 2 years ]
    summary of PK parameters

  2. Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
    assessed per RECIST v1.1

  3. Median duration of response (MDOR) [ Time Frame: Approximately 2 years ]
    assessed per RECIST v1.1

  4. Overall survival rate (OSR) [ Time Frame: Approximately 2 years ]
  5. Incidence of Adverse Events (AE) [ Time Frame: Approximately 2 years ]
  6. Incidence of Serious Adverse Events (SAE) [ Time Frame: Approximately 2 years ]
  7. Incidence of death [ Time Frame: Approximately 2 years ]
  8. Incidence of laboratory abnormalities [ Time Frame: Approximately 2 years ]
  9. Incidence of Adverse Events (AE) leading to discontinuation [ Time Frame: Approximately 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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

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 #.

  Show 39 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03336216     History of Changes
Other Study ID Numbers: CA025-006
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

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
Camptothecin
Oxaliplatin
Nivolumab
Albumin-Bound Paclitaxel
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