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CheckMate 9N9: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03377361
Collaborator
Novartis (Industry)
232
Enrollment
102
Locations
6
Arms
95.9
Anticipated Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2018
Anticipated Primary Completion Date :
Jan 16, 2023
Anticipated Study Completion Date :
Jan 30, 2026

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Mekinist

    • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy
  • BMS-734016

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of dose limiting toxicity (DLTs) [Up to 23 months]

    2. Incidence of Adverse Events (AEs) [Approximately 100 months]

    3. Incidence of Serious Adverse Events (SAEs) [Approximately 100 months]

    4. Incidence of Deaths [Up to 100 months]

    5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 77 months]

    6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 77 months]

    7. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 77 months]

    8. Objective response rate (ORR) by investigator (Part 1B and Part 2) [Approximately 24 months]

    Secondary Outcome Measures

    1. Objective response rate (ORR) (Part 1A and Part 1) [Approximately 24 months]

    2. Disease control rate (DCR) [Approximately 24 months]

    3. Duration of response (DOR) [Approximately 24 months]

    4. Time to response (TTR) [Approximately 24 months]

    5. Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 [Approximately 24 months]

    6. Best overall response (BOR) [Up to 24 months]

    7. Overall survival (OS) [Approximately 40 months]

    8. Incidence of Adverse Events (AEs) [Approximately 100 months]

    9. Incidence of Serious Adverse Events (SAEs) [Approximately 100 months]

    10. Incidence of Deaths [Up to 100 months]

    11. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 77 months]

    12. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 77 months]

    13. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 77 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35249
    2 Mayo Clinic Hospital Phoenix Arizona United States 85054
    3 USC Norris Comprehensive Cancer Center Los Angeles California United States 90033
    4 Usc Los Angeles California United States 90033
    5 Ucsf Cancer Center San Francisco California United States 94158
    6 Poudre Valley Health System Fort Collins Colorado United States 80598
    7 Local Institution North Haven Connecticut United States 06473
    8 UF Health Medical Oncology - Davis Cancer Pavilion Gainesville Florida United States 32606
    9 Local Institution Miami Florida United States 33136
    10 Local Institution Marietta Georgia United States 30060
    11 Local Institution Indianapolis Indiana United States 46202
    12 Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Baltimore Maryland United States 21287
    13 Local Institution Boston Massachusetts United States 02114
    14 Beth Israel Desc. Med Ctr Boston Massachusetts United States 02215
    15 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    16 Mayo Clinic Rochester Minnesota United States 55905
    17 Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi United States 39401
    18 Local Institution Saint Louis Missouri United States 63110
    19 Laura & Isaac Perlmutter Cancer Ctr at NYU Langone New York New York United States 10016
    20 Laura and Isaac Perlmutter Cancer Center at Ambulatory Care Center New York New York United States 10016
    21 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    22 Levine Cancer Institute Charlotte North Carolina United States 28204
    23 Local Institution Durham North Carolina United States 27710
    24 Ann B. Barshinger Cancer Institute Lancaster Pennsylvania United States 17604
    25 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    26 Local Institution Philadelphia Pennsylvania United States 19107
    27 MD Anderson Cancer Center Houston Texas United States 77030
    28 Local Institution Temple Texas United States 76508
    29 University Of Wisconsin Madison Wisconsin United States 53792-0001
    30 Local Institution Capital Federal Buenos Aires Argentina 1264
    31 Local Institution Ciudad Autonoma Beunos Aires Buenos Aires Argentina 1431
    32 Local Institution - 0122 Buenos Aires Distrito Federal Argentina C1096AAS
    33 Local Institution - 0120 Capital Federal Distrito Federal Argentina C1428
    34 Local Institution Ciudad Autónoma de Buenos Aires Distrito Federal Argentina 1181
    35 Local Institution Viedma RIO Negro Argentina 8500
    36 Local Institution Viedma RIO Negro Argentina 8500
    37 Local Institution - 0119 Buenos Aires Argentina 1431
    38 Local Institution Caba Argentina 1199
    39 Local Institution Caba Argentina 1426
    40 Local Institution - 0044 Blacktown New South Wales Australia 2148
    41 Local Institution Herston Queensland Australia
    42 Local Institution - 0043 Southport Queensland Australia 4215
    43 Local Institution - 0068 Elizabeth Vale South Australia Australia 05112
    44 Local Institution - 0055 Clayton Victoria Australia 0
    45 Local Institution - 0069 Heidelberg Victoria Australia 3084
    46 Local Institution Brussels Belgium 1000
    47 Local Institution Brussels Belgium B-1000
    48 Local Institution Brussel Belgium 1090
    49 Local Institution Bruxelles Belgium 1200
    50 Local Institution Edegem Belgium 2650
    51 Local Institution Gent Belgium 9000
    52 Local Institution Leuven Belgium 3000
    53 Local Institution Liège Belgium 4000
    54 Local Institution Woluwe-Saint-Lambert Belgium 1200
    55 Local Institution Edmonton Alberta Canada T6G 1Z2
    56 Local Institution Ottawa Ontario Canada
    57 Local Institution - 0070 Toronto Ontario Canada M5G 2M9
    58 Local Institution Toronto Ontario Canada M5G1X5
    59 Local Institution Toronto Ontario Canada
    60 Local Institution - 0077 Montréal Quebec Canada H2X 3E4
    61 Local Institution - 0076 Ottawa Canada K1H 8L6
    62 Local Institution Quebec Canada
    63 Local Institution - 0117 Santiago Metropolitana Chile 000000
    64 Local Institution - 0118 Santiago Metropolitana Chile 8420383
    65 Local Institution Brno Czechia 625 00
    66 Local Institution Brno Czechia 656 53
    67 Local Institution - 0071 Brno Czechia 65653
    68 Local Institution Hradec Kralove Czechia 500 05
    69 Local Institution - 0073 Hradec Kralove Czechia 50005
    70 Fakultni nemocnice Olomouc-Onkologicka klinika Olomouc Czechia 77900
    71 Local Institution Cologne Germany 50937
    72 Local Institution Hamburg Germany 20251
    73 Local Institution Hannover Germany 30625
    74 Local Institution Heilbronn Germany 74078
    75 Local Institution Mannheim Germany 68163
    76 Local Institution Munich Germany 81377
    77 Local Institution Ulm Germany 89081
    78 Local Institution Wuerzburg Germany 97080
    79 Local Institution Catania Italy 95122
    80 Local Institution Milano Italy 20133
    81 Local Institution - 0093 Milan Italy 20133
    82 Local Institution Modena Italy 41124
    83 Local Institution - 0092 Padova Italy 35128
    84 Local Institution Padova Italy Padova
    85 Local Institution - 0094 Rozzano Italy 20089
    86 Local Institution Moscow Russian Federation 115478
    87 Local Institution Rostov-on-don Russian Federation 344037
    88 Local Institution - 0079 Badalona Spain 08916
    89 Local Institution - 0052 Barcelona Spain 08035
    90 Local Institution - 0114 Madrid Spain 28007
    91 Local Institution - 0051 Madrid Spain 28041
    92 Local Institution - 0115 Madrid Spain 28050
    93 Local Institution Madrid Spain 28050
    94 Local Institution - 0080 Pamplona Spain 31008
    95 Local Institution - 0096 Sevilla Spain 41013
    96 Local Institution Aberdeen Aberdeenshire United Kingdom AB25 2ZN
    97 Local Institution Bristol Avon United Kingdom BS2 8ED
    98 Local Institution London Greater London United Kingdom SW17 ORE
    99 Local Institution London Greater London United Kingdom SW3 6JJ
    100 Local Institution Coventry United Kingdom CV2 2DX
    101 Local Institution Manchester United Kingdom M20 4BX
    102 Local Institution Surrey United Kingdom sm2 5pt

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Novartis

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03377361
    Other Study ID Numbers:
    • CA209-9N9
    • 2017-001830-24
    First Posted:
    Dec 19, 2017
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Nivolumab
    Ipilimumab
    Trametinib

    Study Results

    No Results Posted as of Jun 14, 2022