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

NCT03336216 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CA025-006
• Study Type: interventional
• Target: 205
• Locations: 11 countries
• Sites: 41

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.

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) by BICR

  PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)

Secondary Outcomes (15)

• Progression Free Survival (PFS) by Investigator

  From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)

• Progression Free Survival Rate (PFSR) by BICR

  At 6, 9, and 12 months

• Progression Free Survival Rate (PFSR) by Investigator

  At 6, 9, and 12 months

• Objective Response Rate (ORR) by BICR

  From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months)

• Objective Response Rate (ORR) by Investigator

  From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months)

Study Arms (4)

Arm A

ACTIVE COMPARATOR

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

Drug: Nab-paclitaxel; Drug: Onivyde; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Leucovorin; Drug: Irinotecan Hydrochloride

Arm B

EXPERIMENTAL

Cabiralizumab Q2W + Nivolumab Q4W

Biological: Cabiralizumab; Biological: Nivolumab

Arm C

EXPERIMENTAL

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

Biological: Cabiralizumab; Drug: Nab-paclitaxel; Biological: Nivolumab; Drug: Gemcitabine

Arm D

EXPERIMENTAL

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

Biological: Cabiralizumab; Biological: Nivolumab; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin

Interventions

Cabiralizumab BIOLOGICAL

specified dose on specified days

Also known as: BMS-986227, FPA008

Arm B; Arm C; Arm D

Nab-paclitaxel DRUG

specified does on specified days

Also known as: Abraxane

Arm A; Arm C

Onivyde DRUG

specified dose on specified days

Also known as: irinotecan liposome

Arm A

Nivolumab BIOLOGICAL

specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm B; Arm C; Arm D

Fluorouracil DRUG

specified dose on specified days

Also known as: 5-Fluorouracil

Arm A; Arm D

Gemcitabine DRUG

specified dose on specified days

Arm A; Arm C

Oxaliplatin DRUG

specified dose on specified day

Arm D

Leucovorin DRUG

Specified dose on specified days

Arm A; Arm D

Irinotecan Hydrochloride DRUG

Specified dose on specified days

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (41)

Mayo Clinic in Rochester, Minnesota

Phoenix, Arizona, 85054, United States

Location

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Local Institution - 0007

Los Angeles, California, 90095, United States

Location

University Of Colorado

Aurora, Colorado, 80045, United States

Location

Florida Cancer Specialists - South

Fort Myers, Florida, 33901, United States

Location

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0001

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute.

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0010

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Local Institution - 0012

New York, New York, 10016, United States

Location

Local Institution - 0005

New York, New York, 10065, United States

Location

Local Institution - 0006

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0009

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennessee Oncology Chattanooga

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0013

Dallas, Texas, 75390, United States

Location

Local Institution - 0011

Houston, Texas, 77030, United States

Location

University Of Washington

Seattle, Washington, 98109, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0037

Kingston, Ontario, K7L 2V7, Canada

Location

Local Institution - 0035

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0041

Herlev, 2730, Denmark

Location

Local Institution - 0032

Heidelberg, 69120, Germany

Location

Local Institution - 0029

Mannheim, 68167, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Local Institution - 0030

Würzburg, 97080, Germany

Location

Local Institution - 0025

Padua, Padova, Italy

Location

Local Institution - 0026

Roma, 00168, Italy

Location

Local Institution - 0023

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution - 0022

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 0018

Seoul, 03080, South Korea

Location

Local Institution - 0017

Seoul, 06351, South Korea

Location

Local Institution - 0021

Barcelona, 08035, Spain

Location

Local Institution - 0019

Madrid, 28007, Spain

Location

Local Institution - 0020

Madrid, 28041, Spain

Location

Local Institution - 0033

Chur, 7000, Switzerland

Location

Local Institution - 0034

Lausanne, 1011, Switzerland

Location

Local Institution - 0024

Taipei, 100, Taiwan

Location

Local Institution - 0031

Taipei, 112, Taiwan

Location

Local Institution - 0016

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

cabiralizumab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; irinotecan sucrosofate; Nivolumab; Fluorouracil; Gemcitabine; Oxaliplatin; Leucovorin; Irinotecan

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Coordination Complexes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: December 18, 2017
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-07

Locations

US (19); DK (1); CA (3); JP (2); KR (2); DE (4); TW (2); ES (3); GB (1); CH (2); IT (2)