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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
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

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0119
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Local Institution - 0123
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Local Institution - 0122
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Local Institution - 0120
Coordinator of this site? Confirm its status
Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Local Institution - 0044
Coordinator of this site? Confirm its status
BlacktownAustraliaUnknown status
Local Institution - 0055
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Local Institution - 0068
Coordinator of this site? Confirm its status
Elizabeth ValeAustraliaUnknown status
Local Institution - 0069
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Local Institution - 0043
Coordinator of this site? Confirm its status
SouthportAustraliaUnknown status
Local Institution
Coordinator of this site? Confirm its status
Woluwe-Saint-LambertBelgiumUnknown status
Local Institution - 0113
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Local Institution - 0077
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Local Institution - 0076
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Local Institution - 0070
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Local Institution - 0118
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0117
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0071
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
Local Institution - 0073
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Hradec KrálovéCzechiaUnknown status
Local Institution - 0072
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OlomoucCzechiaUnknown status
Local Institution - 0004
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HanoverGermanyUnknown status
Local Institution - 0079
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BadalonaSpainUnknown status
Local Institution - 0052
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Local Institution - 0114
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0115
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0051
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0080
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PamplonaSpainUnknown status
Local Institution - 0096
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Local Institution - 0095
Coordinator of this site? Confirm its status
CataniaItalyUnknown status
Local Institution - 0093
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Local Institution - 0092
Coordinator of this site? Confirm its status
PadovaItalyUnknown status
Local Institution - 0094
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RozzanoItalyUnknown status
Local Institution - 0028
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BaltimoreUnited StatesUnknown status
Local Institution - 0022
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Local Institution - 0029
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CharlotteUnited StatesUnknown status
Local Institution - 0107
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
Local Institution - 0116
Coordinator of this site? Confirm its status
HattiesburgUnited StatesUnknown status
Local Institution - 0100
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LancasterUnited StatesUnknown status
Local Institution - 0067
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Los AngelesUnited StatesUnknown status
Local Institution - 0027
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Los AngelesUnited StatesUnknown status
Local Institution - 0002
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MadisonUnited StatesUnknown status
Local Institution - 0111
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MiamiUnited StatesUnknown status
Local Institution - 0104
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New YorkUnited StatesUnknown status
Local Institution - 0003
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PhiladelphiaUnited StatesUnknown status
Thomas Jefferson University - Clinical Research Institute
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PhiladelphiaUnited StatesUnknown status
Local Institution - 0001
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Local Institution - 0103
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Local Institution - 0101
Coordinator of this site? Confirm its status
TempleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.