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Completed

NCT Number: NCT03377361

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Carcinoma Colorectal Neoplasm Colorectal Neoplasms Colorectal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0120, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo, BMS-936558

Trametinib

Drug

Specified dose on specified days

Other names: Mekinist

Ipilimumab

Biological

Specified dose on specified days

Other names: Yervoy, BMS-734016

regorafenib

Drug

Specified dose on specified days

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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).

Secondary outcomes

  1. 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).

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Novartis

Registry information

Official study title

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

Acronym: CheckMate 9N9

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2017
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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