NCT02060188CompletedPhase 2
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
Source: ClinicalTrials.gov · Last updated 6 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 385 (actual)
- First submitted
- 18 Dec 2013
- Start date
- 12 Mar 2014
- Primary completion date
- 22 Oct 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Colorectal cancer
- NCT number
- NCT02060188
- EU CT number
- 2024-516004-42-01
- EudraCT number
- 2013-003939-30
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 385
- From 12 Mar 2014 to the primary completion date, 22 Oct 2024
- 30 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Prior malignancy active within the previous 3 years except for locally curable cancers
- Participants with active, known or suspected autoimmune disease
Other
- Active brain metastases or leptomeningeal metastases are not allowed
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.