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An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread

NCT ID: NCT03414983

Last Updated: 2023-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2022-12-28

Brief Summary

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This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).

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Detailed Description

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Conditions

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Colorectal 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

Nivo + SOC

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Arm B

SOC

Group Type ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Oxaliplatin

Specified dose on specified days

Intervention Type DRUG

Leucovorin

Specified dose on specified days

Intervention Type DRUG

Fluorouracil

Specified dose on specified days

Intervention Type DRUG

Bevacizumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558 Opdivo Calcium Folinate Avastin

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
* No prior chemotherapy for metastatic colorectal cancer
* ECOG Performance Status of 0-1
* Ability to provide adequate tissue sample

Exclusion Criteria

* Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Suibb

Locations

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Uab Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Local Institution - 0004

Los Angeles, California, United States

Site Status

Local Institution - 0010

Aurora, Colorado, United States

Site Status

Local Institution - 0027

Denver, Colorado, United States

Site Status

Local Institution - 0020

New Haven, Connecticut, United States

Site Status

Local Institution - 0039

Miami, Florida, United States

Site Status

Local Institution - 0047

St. Petersburg, Florida, United States

Site Status

Local Institution - 0033

Arlington Heights, Illinois, United States

Site Status

Local Institution - 0044

Indianapolis, Indiana, United States

Site Status

Local Institution - 0021

Bethesda, Maryland, United States

Site Status

Local Institution - 0003

Boston, Massachusetts, United States

Site Status

Local Institution - 0049

Boston, Massachusetts, United States

Site Status

Local Institution - 0052

Boston, Massachusetts, United States

Site Status

Local Institution - 0053

Boston, Massachusetts, United States

Site Status

Local Institution - 0035

Minneapolis, Minnesota, United States

Site Status

Local Institution - 0002

Rochester, Minnesota, United States

Site Status

Local Institution - 0032

Papillion, Nebraska, United States

Site Status

Local Institution - 0029

Henderson, Nevada, United States

Site Status

Local Institution - 0031

Johnson City, New York, United States

Site Status

Local Institution - 0046

New York, New York, United States

Site Status

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Local Institution - 0038

Portland, Oregon, United States

Site Status

Local Institution - 0005

Philadelphia, Pennsylvania, United States

Site Status

Local Institution - 0024

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0023

Sioux Falls, South Dakota, United States

Site Status

Erlanger Oncology & Hematology - Univ. of TN

Chattanooga, Tennessee, United States

Site Status

Local Institution - 0019

Nashville, Tennessee, United States

Site Status

Local Institution - 0026

Bedford, Texas, United States

Site Status

Local Institution - 0034

Dallas, Texas, United States

Site Status

Local Institution - 0037

Fort Worth, Texas, United States

Site Status

Local Institution - 0040

San Antonio, Texas, United States

Site Status

Local Institution - 0036

Tyler, Texas, United States

Site Status

Local Institution - 0025

Richmond, Virginia, United States

Site Status

Local Institution - 0028

Roanoke, Virginia, United States

Site Status

Local Institution - 0006

Madison, Wisconsin, United States

Site Status

Local Institution - 0017

Edmonton, Alberta, Canada

Site Status

Local Institution - 0015

Ottawa, Ontario, Canada

Site Status

Local Institution - 0014

Toronto, Ontario, Canada

Site Status

Local Institution - 0048

Montreal, Quebec, Canada

Site Status

Local Institution - 0012

Québec, Quebec, Canada

Site Status

Local Institution - 0013

Sherbrooke, Quebec, Canada

Site Status

Local Institution - 0016

Trois-Rivières, Quebec, Canada

Site Status

Local Institution - 0055

Nagoya, Aichi-ken, Japan

Site Status

Local Institution - 0051

Kashiwa-shi, Chiba, Japan

Site Status

Local Institution - 0050

Sunto-gun, Shizuoka, Japan

Site Status

Local Institution - 0009

San Juan, , Puerto Rico

Site Status

Local Institution - 0043

Barcelona, , Spain

Site Status

Local Institution - 0042

Madrid, , Spain

Site Status

Local Institution - 0041

Majadahonda - Madrid, , Spain

Site Status

Countries

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United States Canada Japan Puerto Rico Spain

References

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Lenz HJ, Parikh A, Spigel DR, Cohn AL, Yoshino T, Kochenderfer M, Elez E, Shao SH, Deming D, Holdridge R, Larson T, Chen E, Mahipal A, Ucar A, Cullen D, Baskin-Bey E, Kang T, Hammell AB, Yao J, Tabernero J. Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial. J Immunother Cancer. 2024 Mar 13;12(3):e008409. doi: 10.1136/jitc-2023-008409.

Reference Type DERIVED
PMID: 38485190 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2017-003662-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-9X8

Identifier Type: -

Identifier Source: org_study_id

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