NCT03377361CompletedPhase 1/2
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 325 (actual)
- First submitted
- 14 Dec 2017
- Start date
- 31 Jan 2018
- Primary completion date
- 4 Nov 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Colorectal cancer
- NCT number
- NCT03377361
- EudraCT number
- 2017-001830-24
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 325
- From 31 Jan 2018 to the primary completion date, 4 Nov 2024
- 47 sites in 10 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
- Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
Other illness
- BRAF V600 mutant colorectal cancer
- Active, known or suspected autoimmune disease
- History of interstitial lung disease or pneumonitis
- History of allergy or hypersensitivity to study drug components
- Other protocol defined inclusion/exclusion criteria apply
Other
- Active brain metastases or leptomeningeal metastases
Who the study is looking for
- Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
- Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
- Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0119 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Elizabeth Vale | Australia | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Unknown status |
| Local Institution - 0113 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Local Institution - 0118 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0117 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0115 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Local Institution - 0107 Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Thomas Jefferson University - Clinical Research Institute Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.