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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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
Hide Hide 83 study locations
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United States, Alabama
University Of Alabama At Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Hospital Withdrawn
Phoenix, Arizona, United States, 85054
United States, California
USC Norris Comprehensive Cancer Center Active, not recruiting
Los Angeles, California, United States, 90033
Usc Completed
Los Angeles, California, United States, 90033
Ucsf Cancer Center Active, not recruiting
San Francisco, California, United States, 94158
United States, Colorado
Poudre Valley Health System Withdrawn
Fort Collins, Colorado, United States, 80598
United States, Georgia
Local Institution Not yet recruiting
Marietta, Georgia, United States, 30060
Contact: Site 0098         
United States, Indiana
Local Institution Withdrawn
Indianapolis, Indiana, United States, 46202
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Withdrawn
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Withdrawn
Boston, Massachusetts, United States, 02114
Beth Israel Desc. Med Ctr Withdrawn
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute Withdrawn
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Withdrawn
Rochester, Minnesota, United States, 55905
United States, New York
Laura & Isaac Perlmutter Cancer Ctr at NYU Langone Withdrawn
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center Withdrawn
New York, New York, United States, 10065
Yale Cancer Center Withdrawn
New York, New York, United States, 10065
United States, North Carolina
Local Institution Not yet recruiting
Charlotte, North Carolina, United States, 28262
Contact: Site 0029         
Local Institution Withdrawn
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University Of Pennsylvania Completed
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MD Anderson Cancer Center Withdrawn
Houston, Texas, United States, 77030
United States, Wisconsin
University Of Wisconsin Completed
Madison, Wisconsin, United States, 53705
Argentina
Local Institution Withdrawn
Capital Federal, Buenos Aires, Argentina, 1264
Local Institution Withdrawn
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
Local Institution Withdrawn
Viedma, RIO Negro, Argentina, 8500
Local Institution Withdrawn
Caba, Argentina, 1199
Local Institution Withdrawn
Caba, Argentina, 1426
Australia, New South Wales
Local Institution Not yet recruiting
Blacktown, New South Wales, Australia, 2145
Contact: Site 0044         
Australia, Queensland
Local Institution Withdrawn
Herston, Queensland, Australia
Local Institution Not yet recruiting
Southport, Queensland, Australia, 4215
Contact: Site 0043         
Australia, South Australia
Local Institution Not yet recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Site 0068         
Australia, Victoria
Local Institution Not yet recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0055         
Local Institution Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0069         
Belgium
Local Institution Recruiting
Brussels, Belgium, 1000
Contact: Site 0086         
Local Institution Withdrawn
Brussels, Belgium, B-1000
Local Institution Withdrawn
Brussel, Belgium, 1090
Local Institution Withdrawn
Bruxelles, Belgium, 1200
Local Institution Not yet recruiting
Edegem, Belgium, 2650
Contact: Site 0090         
Local Institution Not yet recruiting
Gent, Belgium, 9000
Contact: Site 0089         
Local Institution Withdrawn
Leuven, Belgium, 3000
Local Institution Not yet recruiting
Leuven, Belgium, 3000
Contact: Site 0088         
Local Institution Not yet recruiting
Woluwe-Saint-Lambert, Belgium, 1200
Contact: Site 0087         
Canada, Ontario
Local Institution Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 0076         
Local Institution Withdrawn
Ottawa, Ontario, Canada
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0070         
Local Institution Withdrawn
Toronto, Ontario, Canada
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Site 0077         
Canada
Local Institution Withdrawn
Quebec, Canada
Czechia
Local Institution Withdrawn
Brno, Czechia, 625 00
Local Institution Withdrawn
Brno, Czechia, 656 53
Local Institution Not yet recruiting
Brno, Czechia, 656 53
Contact: Site 0071         
Local Institution Withdrawn
Hradec Kralove, Czechia, 500 05
Local Institution Not yet recruiting
Hradec Kralove, Czechia, 500 05
Contact: Site 0073         
Local Institution Not yet recruiting
Olomouc, Czechia, 77900
Contact: Site 0072         
Germany
Local Institution Withdrawn
Cologne, Germany, 50937
Local Institution Withdrawn
Hamburg, Germany, 20251
Local Institution Withdrawn
Hannover, Germany, 30625
Local Institution Withdrawn
Heilbronn, Germany, 74078
Local Institution Withdrawn
Mannheim, Germany, 68163
Local Institution Withdrawn
Munich, Germany, 81377
Local Institution Withdrawn
Ulm, Germany, 89081
Local Institution Withdrawn
Wuerzburg, Germany, 97080
Italy
Local Institution Not yet recruiting
Catania, Italy, 95122
Contact: Site 0095         
Local Institution Withdrawn
Milano, Italy, 20133
Local Institution Not yet recruiting
Milano, Italy, 20133
Contact: Site 0093         
Local Institution Withdrawn
Modena, Italy, 41124
Local Institution Not yet recruiting
Padova, Italy, 35128
Contact: Site 0092         
Local Institution Withdrawn
Padova, Italy, Padova
Local Institution Not yet recruiting
Rozzano, Italy, 20089
Contact: Site 0094         
Russian Federation
Local Institution Withdrawn
Moscow, Russian Federation, 115478
Local Institution Not yet recruiting
Rostov-on-don, Russian Federation, 344037
Contact: Site 0064         
Spain
Local Institution Not yet recruiting
Badalona, Spain, 08916
Contact: Site 0079         
Local Institution Withdrawn
Barcelona, Spain, 08035
Local Institution Withdrawn
Madrid, Spain, 28041
Local Institution Withdrawn
Madrid, Spain, 28050
Local Institution Not yet recruiting
Pamplona, Spain, 31008
Contact: Site 0080         
Local Institution Not yet recruiting
Seville, Spain, 41013
Contact: Site 0096         
United Kingdom
Local Institution Withdrawn
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
Local Institution Withdrawn
Bristol, Avon, United Kingdom, BS2 8ED
Local Institution Withdrawn
London, Greater London, United Kingdom, SW17 ORE
Local Institution Withdrawn
London, Greater London, United Kingdom, SW3 6JJ
Local Institution Withdrawn
Coventry, United Kingdom, CV2 2DX
Local Institution Withdrawn
Manchester, United Kingdom, M20 4BX
Local Institution Withdrawn
Surrey, United Kingdom, sm2 5pt
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