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 (CheckMate 9N9)

November 20, 2025 updated by: Bristol-Myers Squibb

A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1431
        • Local Institution - 0119
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0120
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, C1096AAS
        • Local Institution - 0122
      • Buenos Aires, Distrito Federal, Argentina, 1181
        • Local Institution - 0123
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution - 0044
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0043
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 05112
        • Local Institution - 0068
    • Victoria
      • Clayton, Victoria, Australia
        • Local Institution - 0055
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0069
  • Belgium
      • Woluwe-Saint-Lambert, Belgium, 1200
        • Local Institution
  • Canada
      • Ottawa, Canada, K1H 8L6
        • Local Institution - 0076
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0113
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0070
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Local Institution - 0077
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 000000
        • Local Institution - 0117
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0118
  • Czechia
      • Brno, Czechia, 65653
        • Local Institution - 0071
      • Hradec Králové, Czechia, 500 05
        • Local Institution - 0073
    • Olomoucký kraj
      • Olomouc, Olomoucký kraj, Czechia, 779 00
        • Local Institution - 0072
  • Germany
      • Hanover, Germany, 30625
        • Local Institution - 0004
  • Italy
      • Catania, Italy, 95124
        • Local Institution - 0095
      • Milan, Italy, 20133
        • Local Institution - 0093
      • Padua, Italy, 35128
        • Local Institution - 0092
      • Rozzano, Italy, 20089
        • Local Institution - 0094
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0052
      • Madrid, Spain, 28007
        • Local Institution - 0114
      • Madrid, Spain, 28041
        • Local Institution - 0051
      • Madrid, Spain, 28050
        • Local Institution - 0115
      • Seville, Spain, 41013
        • Local Institution - 0096
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Local Institution - 0079
    • Navarre
      • Pamplona, Navarre, Spain, 31009
        • Local Institution - 0080
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Local Institution - 0022
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0027
      • Los Angeles, California, United States, 90089
        • Local Institution - 0067
      • San Francisco, California, United States, 94158
        • Local Institution - 0001
    • Florida
      • Gainesville, Florida, United States, 32610
        • Local Institution - 0107
      • Miami, Florida, United States, 33136
        • Local Institution - 0111
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0028
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401-7233
        • Local Institution - 0116
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0103
    • New York
      • New York, New York, United States, 10016
        • Local Institution - 0104
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0029
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Local Institution - 0100
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0003
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University - Clinical Research Institute
    • Texas
      • Temple, Texas, United States, 76508
        • Local Institution - 0101
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-0001
        • Local Institution - 0002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • BRAF V600 mutant colorectal cancer
  • Active brain metastases or leptomeningeal metastases
  • Active, known or suspected autoimmune disease
  • 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
  • History of interstitial lung disease or pneumonitis
  • Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
  • History of allergy or hypersensitivity to study drug components

Other protocol defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Trametinib
Specified dose on specified days
Other Names:
  • Mekinist
Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Trametinib
Specified dose on specified days
Other Names:
  • Mekinist
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Trametinib
Specified dose on specified days
Other Names:
  • Mekinist
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Trametinib
Specified dose on specified days
Other Names:
  • Mekinist
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 2 Cohort 5 (3L): Regorafenib
Drug: Regorafenib
Specified dose on specified days
Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Trametinib
Specified dose on specified days
Other Names:
  • Mekinist
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicities in Part 1 and Part 1A
Time Frame: 4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen
Dose Limiting Toxicities are defined as adverse events have to be at least possibly related to study treatment, and not to disease progression, be clinically relevant and a clinically relevant shift from baseline.
4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen
Safety Related Events in Part 1 and Part 1 A
Time Frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.
Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests
Time Frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Number of participants with clinical laboratory abnormalities in specific thyroid tests
Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests
Time Frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Number of participants with clinical laboratory abnormalities in specific liver tests.
Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Overal Response Rate in Part 1B and Part 2
Time Frame: Approximately up to 30 Months
ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).
Approximately up to 30 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate in Part 1 and Part 1A
Time Frame: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).
From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
Disease Control Rate in Part 1 and Part 1A
Time Frame: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
The disease control rate (DCR) is defined as the percentage of participants whose BOR is either confirmed CR or confirmed PR or stable disease (SD)
From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
Duration of Response in Part 1 and Part 1A
Time Frame: Approximately up to 20 Months
DOR for a participant with a BOR of confirmed CR or PR, is defined as the time between the date of first confirmed response and the date of the first objectively documented tumor progression per RECIST 1.1 or death, whichever occurs first.
Approximately up to 20 Months
Time to Response in Part 1 and Part 1A
Time Frame: From the first dosing date to the date of first documented CR or PR per RECIST 1.1. (Approximately on average 10 months)
Time to response (TTR) is defined for participants who had a confirmed CR or PR as the time from the first dosing date to the date of first documented CR or PR per RECIST 1.1.
From the first dosing date to the date of first documented CR or PR per RECIST 1.1. (Approximately on average 10 months)
Progression Free Survival in Part 1 and Part 1A
Time Frame: from the first dosing date to the date of first objectively documented disease progression or death, whichever occurs first (Approximately up to 21 months)
PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression per RECIST 1.1 (ie, radiologic) or death due to any cause, whichever occurs first.
from the first dosing date to the date of first objectively documented disease progression or death, whichever occurs first (Approximately up to 21 months)
Overall Survival in Part 1 and Part 1A
Time Frame: Approximately up to 69 Months
OS for a participant is defined as the time from the first dosing date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.
Approximately up to 69 Months
Safety Related Events in Part 1B and Part 2
Time Frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.
Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests
Time Frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Number of participants with clinical laboratory abnormalities in specific thyroid tests
Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests
Time Frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Number of participants with clinical laboratory abnormalities in specific liver tests.
Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-9N9
  • 2017-001830-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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