Colon Cancer Clinical Trial

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Summary

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Histologically confirmed recurrent or metastatic colorectal cancer
Measurable disease per RECIST v1.1
Microsatellite instability expression detected by an accredited laboratory
Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion Criteria:

Active brain metastases or leptomeningeal metastases are not allowed
Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Prior malignancy active within the previous 3 years except for locally curable cancers
Participants with active, known or suspected autoimmune disease
Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

385

Study ID:

NCT02060188

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 28 Locations for this study

See Locations Near You

Local Institution - 0028
Gilbert Arizona, 85234, United States
Local Institution - 0004
Los Angeles California, 90033, United States
Local Institution - 0001
San Francisco California, 94115, United States
Local Institution - 0008
Atlanta Georgia, 30322, United States
Local Institution - 0002
Boston Massachusetts, 02114, United States
Local Institution - 0036
Boston Massachusetts, 02114, United States
Allina Health System dba Virginia PIper Cancer Institute
Minneapolis Minnesota, 55407, United States
Local Institution - 0034
Minneapolis Minnesota, 55407, United States
Local Institution - 0024
Durham North Carolina, 27710, United States
Local Institution - 0029
Winston-Salem North Carolina, 27103, United States
Local Institution - 0005
Portland Oregon, 97213, United States
Local Institution - 0041
Allentown Pennsylvania, 18103, United States
Local Institution - 0013
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0006
Nashville Tennessee, 37232, United States
Local Institution - 0003
Houston Texas, 77030, United States
Local Institution - 0040
Westmead New South Wales, 2145, Australia
Local Institution - 0039
Southport Queensland, 4215, Australia
Local Institution - 0037
Melbourne Victoria, 3000, Australia
Local Institution - 0019
Brussels , 1000, Belgium
Local Institution - 0018
Brussels , 1090, Belgium
Local Institution - 0020
Leuven , 3000, Belgium
Local Institution - 0027
Edmonton Alberta, T6G 1, Canada
Local Institution - 0016
Toronto Ontario, M5G 1, Canada
Local Institution - 0025
Paris , 75571, France
Local Institution - 0022
Dublin 4 , 0, Ireland
Local Institution - 0023
Dublin 9 , 0, Ireland
Local Institution - 0033
Galway , 0, Ireland
Local Institution - 0030
Candiolo, Torino , 10060, Italy
Local Institution - 0035
Modena , 41124, Italy
Local Institution - 0032
Padova , Padov, Italy
Local Institution - 0012
Madrid , 28009, Spain
Local Institution - 0010
Madrid , 28050, Spain
Local Institution - 0011
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

385

Study ID:

NCT02060188

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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