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.
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
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There are 28 Locations for this study
Gilbert Arizona, 85234, United States
Los Angeles California, 90033, United States
San Francisco California, 94115, United States
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55407, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27103, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18103, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Westmead New South Wales, 2145, Australia
Southport Queensland, 4215, Australia
Melbourne Victoria, 3000, Australia
Brussels , 1000, Belgium
Brussels , 1090, Belgium
Leuven , 3000, Belgium
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 1, Canada
Paris , 75571, France
Dublin 4 , 0, Ireland
Dublin 9 , 0, Ireland
Galway , 0, Ireland
Candiolo, Torino , 10060, Italy
Modena , 41124, Italy
Padova , Padov, Italy
Madrid , 28009, Spain
Madrid , 28050, Spain
Sevilla , 41013, Spain
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