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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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 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:

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

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 Q2W + Nivolumab Q4W
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 Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
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 Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
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. Progression free survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) by Investigator Assessment [ Time Frame: Up to 12 months ]
  2. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
  3. Objective response rate (ORR) [ Time Frame: Up to 12 Months ]
  4. Duration of response (DOR) [ Time Frame: Up to 12 Months ]
  5. Overall Survival (OS) [ Time Frame: Up to 2 Years ]
  6. Overall survival rate (OSR) [ Time Frame: Up to 2 years ]
  7. Incidence of Adverse Events (AE) [ Time Frame: Approximately 2 years ]
  8. Incidence of Serious Adverse Events (SAE) [ Time Frame: Approximately 2 years ]
  9. Incidence of Adverse Events (AE) leading to discontinuation [ Time Frame: Approximately 2 years ]
  10. Incidence of death [ Time Frame: Approximately 2 years ]
  11. Number of clinically significant changes in lab assessment: Blood [ Time Frame: Approximately 2 years ]
  12. Number of clinically significant changes in lab assessment: Blood Serum [ Time Frame: Approximately 2 years ]
  13. Number of clinically significant changes in lab assessment: Urine [ Time Frame: Approximately 2 years ]


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.


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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


Locations
Show Show 41 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03336216    
Other Study ID Numbers: CA025-006
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Gemcitabine
Paclitaxel
Fluorouracil
Oxaliplatin
Irinotecan
Nivolumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors