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

NCT ID: NCT03336216

Last Updated: 2024-07-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Investigator choice of chemotherapy:

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

Group Type ACTIVE_COMPARATOR

Nab-paclitaxel

Intervention Type DRUG

specified does on specified days

Onivyde

Intervention Type DRUG

specified dose on specified days

Fluorouracil

Intervention Type DRUG

specified dose on specified days

Gemcitabine

Intervention Type DRUG

specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Irinotecan Hydrochloride

Intervention Type DRUG

Specified dose on specified days

Arm B

Cabiralizumab Q2W + Nivolumab Q4W

Group Type EXPERIMENTAL

Cabiralizumab

Intervention Type BIOLOGICAL

specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

specified dose on specified days

Arm C

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

Group Type EXPERIMENTAL

Cabiralizumab

Intervention Type BIOLOGICAL

specified dose on specified days

Nab-paclitaxel

Intervention Type DRUG

specified does on specified days

Nivolumab

Intervention Type BIOLOGICAL

specified dose on specified days

Gemcitabine

Intervention Type DRUG

specified dose on specified days

Arm D

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

Group Type EXPERIMENTAL

Cabiralizumab

Intervention Type BIOLOGICAL

specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

specified dose on specified days

Fluorouracil

Intervention Type DRUG

specified dose on specified days

Oxaliplatin

Intervention Type DRUG

specified dose on specified day

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Interventions

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Cabiralizumab

specified dose on specified days

Intervention Type BIOLOGICAL

Nab-paclitaxel

specified does on specified days

Intervention Type DRUG

Onivyde

specified dose on specified days

Intervention Type DRUG

Nivolumab

specified dose on specified days

Intervention Type BIOLOGICAL

Fluorouracil

specified dose on specified days

Intervention Type DRUG

Gemcitabine

specified dose on specified days

Intervention Type DRUG

Oxaliplatin

specified dose on specified day

Intervention Type DRUG

Leucovorin

Specified dose on specified days

Intervention Type DRUG

Irinotecan Hydrochloride

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986227, FPA008 Abraxane irinotecan liposome Opdivo, BMS-936558 5-Fluorouracil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic in Rochester, Minnesota

Phoenix, Arizona, United States

Site Status

HonorHealth Research Institute

Scottsdale, Arizona, United States

Site Status

Local Institution - 0007

Los Angeles, California, United States

Site Status

University Of Colorado

Aurora, Colorado, United States

Site Status

Florida Cancer Specialists - South

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists - North

St. Petersburg, Florida, United States

Site Status

Local Institution - 0001

Baltimore, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute.

Boston, Massachusetts, United States

Site Status

Local Institution - 0010

Boston, Massachusetts, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Local Institution - 0012

New York, New York, United States

Site Status

Local Institution - 0005

New York, New York, United States

Site Status

Local Institution - 0006

Philadelphia, Pennsylvania, United States

Site Status

Local Institution - 0009

Pittsburgh, Pennsylvania, United States

Site Status

Tennessee Oncology Chattanooga

Nashville, Tennessee, United States

Site Status

Local Institution - 0013

Dallas, Texas, United States

Site Status

Local Institution - 0011

Houston, Texas, United States

Site Status

University Of Washington

Seattle, Washington, United States

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Local Institution - 0037

Kingston, Ontario, Canada

Site Status

Local Institution - 0035

Toronto, Ontario, Canada

Site Status

Local Institution - 0041

Herlev, , Denmark

Site Status

Local Institution - 0032

Heidelberg, , Germany

Site Status

Local Institution - 0029

Mannheim, , Germany

Site Status

Universitaetsklinikum Ulm

Ulm, , Germany

Site Status

Local Institution - 0030

Würzburg, , Germany

Site Status

Local Institution - 0025

Padua, , Italy

Site Status

Local Institution - 0026

Roma, , Italy

Site Status

Local Institution - 0023

Kashiwa-shi, Chiba, Japan

Site Status

Local Institution - 0022

Chuo-ku, Tokyo, Japan

Site Status

Local Institution - 0018

Seoul, , South Korea

Site Status

Local Institution - 0017

Seoul, , South Korea

Site Status

Local Institution - 0021

Barcelona, , Spain

Site Status

Local Institution - 0019

Madrid, , Spain

Site Status

Local Institution - 0020

Madrid, , Spain

Site Status

Local Institution - 0033

Chur, , Switzerland

Site Status

Local Institution - 0034

Lausanne, , Switzerland

Site Status

Local Institution - 0024

Taipei, , Taiwan

Site Status

Local Institution - 0031

Taipei, , Taiwan

Site Status

Local Institution - 0016

Glasgow, Lanarkshire, United Kingdom

Site Status

Countries

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United States Canada Denmark Germany Italy Japan South Korea Spain Switzerland Taiwan United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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CA025-006

Identifier Type: -

Identifier Source: org_study_id

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