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

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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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