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

Primary Purpose

Advanced Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cabiralizumab
Nab-paclitaxel
Onivyde
Nivolumab
Fluorouracil
Gemcitabine
Oxaliplatin
Leucovorin
Irinotecan Hydrochloride
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester, Minnesota
  • HonorHealth Research Institute
  • Local Institution - 0007
  • University Of Colorado
  • Florida Cancer Specialists - South
  • Florida Cancer Specialists - North
  • Johns Hopkins University
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute.
  • Massachusetts General Hospital
  • Washington University
  • Local Institution - 0012
  • Local Institution - 0005
  • Penn Medicine: University of Pennsylvania Health System
  • Local Institution - 0009
  • Tennessee Oncology, PLLC - SCRI - PPDS
  • Local Institution - 0013
  • Local Institution - 0011
  • University Of Washington
  • Cross Cancer Institute
  • Local Institution - 0037
  • Local Institution - 0035
  • Local Institution - 0041
  • Universitaetsklinik Heidelberg
  • Universitatsmedizin Mannheim
  • Universitaetsklinikum Ulm
  • Univ. Klinikum Wuerzburg
  • Local Institution - 0025
  • Local Institution - 0026
  • Local Institution - 0023
  • Local Institution - 0022
  • Local Institution - 0018
  • Local Institution - 0017
  • Local Institution - 0021
  • Local Institution - 0019
  • Local Institution - 0020
  • Local Institution - 0033
  • Local Institution - 0034
  • Local Institution
  • Local Institution - 0031
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm Description

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

Cabiralizumab Q2W + Nivolumab Q4W

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

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

Outcomes

Primary Outcome Measures

Progression free survival (PFS) by Blinded Independent Central Review (BICR)

Secondary Outcome Measures

Progression Free Survival (PFS) by Investigator Assessment
Progression Free Survival Rate (PFSR)
Objective response rate (ORR)
Duration of response (DOR)
Overall Survival (OS)
Overall survival rate (OSR)
Incidence of Adverse Events (AE)
Incidence of Serious Adverse Events (SAE)
Incidence of Adverse Events (AE) leading to discontinuation
Incidence of death
Number of clinically significant changes in lab assessment: Blood
Number of clinically significant changes in lab assessment: Blood Serum
Number of clinically significant changes in lab assessment: Urine

Full Information

First Posted
November 6, 2017
Last Updated
July 6, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03336216
Brief Title
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Cabiralizumab Q2W + Nivolumab Q4W
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
Arm Title
Arm D
Arm Type
Experimental
Arm Description
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
Intervention Type
Biological
Intervention Name(s)
Cabiralizumab
Other Intervention Name(s)
BMS-986227, FPA008
Intervention Description
specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
specified does on specified days
Intervention Type
Drug
Intervention Name(s)
Onivyde
Other Intervention Name(s)
irinotecan liposome
Intervention Description
specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-Fluorouracil
Intervention Description
specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Irinotecan Hydrochloride
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Progression free survival (PFS) by Blinded Independent Central Review (BICR)
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) by Investigator Assessment
Time Frame
Up to 12 months
Title
Progression Free Survival Rate (PFSR)
Time Frame
Up to 12 months
Title
Objective response rate (ORR)
Time Frame
Up to 12 Months
Title
Duration of response (DOR)
Time Frame
Up to 12 Months
Title
Overall Survival (OS)
Time Frame
Up to 2 Years
Title
Overall survival rate (OSR)
Time Frame
Up to 2 years
Title
Incidence of Adverse Events (AE)
Time Frame
Approximately 2 years
Title
Incidence of Serious Adverse Events (SAE)
Time Frame
Approximately 2 years
Title
Incidence of Adverse Events (AE) leading to discontinuation
Time Frame
Approximately 2 years
Title
Incidence of death
Time Frame
Approximately 2 years
Title
Number of clinically significant changes in lab assessment: Blood
Time Frame
Approximately 2 years
Title
Number of clinically significant changes in lab assessment: Blood Serum
Time Frame
Approximately 2 years
Title
Number of clinically significant changes in lab assessment: Urine
Time Frame
Approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Local Institution - 0007
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Florida Cancer Specialists - South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists - North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 0012
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0005
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Penn Medicine: University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 0009
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Tennessee Oncology, PLLC - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution - 0013
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Local Institution - 0011
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 0037
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Local Institution - 0035
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0041
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Universitaetsklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Univ. Klinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 0025
City
Padova
ZIP/Postal Code
Padova
Country
Italy
Facility Name
Local Institution - 0026
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 0023
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution - 0022
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution - 0018
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0017
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0021
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0019
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0020
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0033
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Local Institution - 0034
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 0031
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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