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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Tumors Colorectal Carcinoma Colorectal Neoplasm Biological: Nivolumab Drug: Trametinib Biological: Ipilimumab Drug: Regorafenib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 16, 2023
Estimated Study Completion Date : January 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Trametinib
Specified dose on specified days
Other Name: Mekinist

Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib 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

Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib 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

Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib 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

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:
  • 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




Primary Outcome Measures :
  1. Incidence of dose limiting toxicity (DLTs) [ Time Frame: Up to 23 months ]
  2. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 100 months ]
  3. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 100 months ]
  4. Incidence of Deaths [ Time Frame: Up to 100 months ]
  5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 77 months ]
  6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 77 months ]
  7. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 77 months ]
  8. Objective response rate (ORR) by investigator (Part 1B and Part 2) [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) (Part 1A and Part 1) [ Time Frame: Approximately 24 months ]
  2. Disease control rate (DCR) [ Time Frame: Approximately 24 months ]
  3. Duration of response (DOR) [ Time Frame: Approximately 24 months ]
  4. Time to response (TTR) [ Time Frame: Approximately 24 months ]
  5. Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 [ Time Frame: Approximately 24 months ]
  6. Best overall response (BOR) [ Time Frame: Up to 24 months ]
  7. Overall survival (OS) [ Time Frame: Approximately 40 months ]
  8. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 100 months ]
  9. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 100 months ]
  10. Incidence of Deaths [ Time Frame: Up to 100 months ]
  11. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 77 months ]
  12. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 77 months ]
  13. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 77 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377361


Contacts
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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 #.

Locations
Show Show 83 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Novartis
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03377361    
Other Study ID Numbers: CA209-9N9
2017-001830-24 ( EudraCT Number )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nivolumab
Ipilimumab
Trametinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action