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

Advanced Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336216
• Other study ID #: CA025-006
• Status: Completed
• Phase: Phase 2
• Start date: December 19, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• Cabiralizumab
specified dose on specified days

Drug:
• Nab-paclitaxel
specified does on specified days
• Onivyde
specified dose on specified days

Biological:
• Nivolumab
specified dose on specified days

Drug:
• Fluorouracil
specified dose on specified days
• Gemcitabine
specified dose on specified days
• Oxaliplatin
specified dose on specified day
• Leucovorin
Specified dose on specified days
• Irinotecan Hydrochloride
Specified dose on specified days

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Local Institution - 0037	Kingston	Ontario
Canada	Local Institution - 0035	Toronto	Ontario
Denmark	Local Institution - 0041	Herlev
Germany	Universitaetsklinik Heidelberg	Heidelberg
Germany	Universitatsmedizin Mannheim	Mannheim
Germany	Universitaetsklinikum Ulm	Ulm
Germany	Univ. Klinikum Wuerzburg	Wuerzburg
Italy	Local Institution - 0025	Padova
Italy	Local Institution - 0026	Roma
Japan	Local Institution - 0022	Chuo-ku	Tokyo
Japan	Local Institution - 0023	Kashiwa-shi	Chiba
Korea, Republic of	Local Institution - 0017	Seoul
Korea, Republic of	Local Institution - 0018	Seoul
Spain	Local Institution - 0021	Barcelona
Spain	Local Institution - 0019	Madrid
Spain	Local Institution - 0020	Madrid
Switzerland	Local Institution - 0033	Chur
Switzerland	Local Institution - 0034	Lausanne
Taiwan	Local Institution	Taipei
Taiwan	Local Institution - 0031	Taipei
United Kingdom	Local Institution	Glasgow
United States	University Of Colorado	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute.	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Local Institution - 0013	Dallas	Texas
United States	Florida Cancer Specialists - South	Fort Myers	Florida
United States	Local Institution - 0011	Houston	Texas
United States	Local Institution - 0007	Los Angeles	California
United States	Tennessee Oncology, PLLC - SCRI - PPDS	Nashville	Tennessee
United States	Local Institution - 0005	New York	New York
United States	Local Institution - 0012	New York	New York
United States	Penn Medicine: University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Mayo Clinic in Rochester, Minnesota	Phoenix	Arizona
United States	Local Institution - 0009	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Florida Cancer Specialists - North	Saint Petersburg	Florida
United States	HonorHealth Research Institute	Scottsdale	Arizona
United States	University Of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Italy,  Japan,  Korea, Republic of,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) by Blinded Independent Central Review (BICR)		Up to 12 months
Secondary	Progression Free Survival (PFS) by Investigator Assessment		Up to 12 months
Secondary	Progression Free Survival Rate (PFSR)		Up to 12 months
Secondary	Objective response rate (ORR)		Up to 12 Months
Secondary	Duration of response (DOR)		Up to 12 Months
Secondary	Overall Survival (OS)		Up to 2 Years
Secondary	Overall survival rate (OSR)		Up to 2 years
Secondary	Incidence of Adverse Events (AE)		Approximately 2 years
Secondary	Incidence of Serious Adverse Events (SAE)		Approximately 2 years
Secondary	Incidence of Adverse Events (AE) leading to discontinuation		Approximately 2 years
Secondary	Incidence of death		Approximately 2 years
Secondary	Number of clinically significant changes in lab assessment: Blood		Approximately 2 years
Secondary	Number of clinically significant changes in lab assessment: Blood Serum		Approximately 2 years
Secondary	Number of clinically significant changes in lab assessment: Urine		Approximately 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting