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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)

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ClinicalTrials.gov Identifier: NCT03377361
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date January 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • Incidence of dose limiting toxicity (DLTs) [ Time Frame: Up to 23 months ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Approximately 100 months ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 100 months ]
  • Incidence of Deaths [ Time Frame: Up to 100 months ]
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 77 months ]
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 77 months ]
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 77 months ]
  • Objective response rate (ORR) by investigator (Part 1B and Part 2) [ Time Frame: Approximately 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • Number of Adverse Events (AEs) [ Time Frame: Approximately 40 months ]
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Approximately 40 months ]
  • Objective response rate (ORR) [ Time Frame: Approximately 20 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • Objective response rate (ORR) (Part 1A and Part 1) [ Time Frame: Approximately 24 months ]
  • Disease control rate (DCR) [ Time Frame: Approximately 24 months ]
  • Duration of response (DOR) [ Time Frame: Approximately 24 months ]
  • Time to response (TTR) [ Time Frame: Approximately 24 months ]
  • Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 [ Time Frame: Approximately 24 months ]
  • Best overall response (BOR) [ Time Frame: Up to 24 months ]
  • Overall survival (OS) [ Time Frame: Approximately 40 months ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Approximately 100 months ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 100 months ]
  • Incidence of Deaths [ Time Frame: Up to 100 months ]
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 77 months ]
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 77 months ]
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 77 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • Disease control rate (DCR) [ Time Frame: Approximately 20 months ]
  • Duration of response (DOR) [ Time Frame: Approximately 20 months ]
  • Time to response (TTR) [ Time Frame: Approximately 20 months ]
  • Progression free survival (PFS) [ Time Frame: Approximately 20 months ]
  • Overall survival (OS) [ Time Frame: Approximately 40 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Colorectal Tumors
  • Colorectal Carcinoma
  • Colorectal Neoplasm
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: Trametinib
    Specified dose on specified days
    Other Name: Mekinist
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
    • Yervoy
    • BMS-734016
  • Drug: Regorafenib
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
    Interventions:
    • Biological: Nivolumab
    • Drug: Trametinib
  • Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
    Interventions:
    • Biological: Nivolumab
    • Drug: Trametinib
    • Biological: Ipilimumab
  • Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
    Interventions:
    • Biological: Nivolumab
    • Drug: Trametinib
    • Biological: Ipilimumab
  • Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
    Interventions:
    • Biological: Nivolumab
    • Drug: Trametinib
    • Biological: Ipilimumab
  • Experimental: Part 2 Cohort 5 (3L): Regorafenib
    Intervention: Drug: Regorafenib
  • Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
    Interventions:
    • Biological: Nivolumab
    • Drug: Trametinib
    • Biological: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2021)
232
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2017)
345
Estimated Study Completion Date  ICMJE January 30, 2026
Estimated Primary Completion Date January 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Czechia,   Germany,   Italy,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03377361
Other Study ID Numbers  ICMJE CA209-9N9
2017-001830-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP