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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)

  • Clinicaltrials.gov identifier

    NCT03377361

  • Recruitment Status

    Recruiting

  • First Posted

    December 19, 2017

  • Last update posted

    June 14, 2022

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:Colorectal Cancer
    Colorectal Tumors
    Colorectal Carcinoma
    Colorectal Neoplasm
  • Intervention/Treatment: Biological: Nivolumab
    Drug: Trametinib
    Biological: Ipilimumab
    Drug: Regorafenib
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 232 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: February 2018
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: January 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
Biological: Nivolumab
Specified dose on specified days

Drug: Trametinib
Specified dose on specified days
Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days

Drug: Trametinib
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days

Drug: Trametinib
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days

Drug: Trametinib
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab
Specified dose on specified days

Drug: Trametinib
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 2 Cohort 5 (3L): Regorafenib
Drug: Regorafenib
Specified dose on specified days

Outcome Measures

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

Eligibility Criteria

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

Criteria

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

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham

United States, Arizona
Mayo Clinic Hospital
Phoenix

United States, California
USC Norris Comprehensive Cancer Center
Los Angeles

United States, California
Usc
Los Angeles

United States, California
Ucsf Cancer Center
San Francisco

United States, Colorado
Poudre Valley Health System
Fort Collins

United States, Connecticut
Local Institution
North Haven

United States, Florida
UF Health Medical Oncology - Davis Cancer Pavilion
Gainesville

United States, Florida
Local Institution
Miami

United States, Georgia
Local Institution
Marietta

United States, Indiana
Local Institution
Indianapolis

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore

United States, Massachusetts
Local Institution
Boston

United States, Massachusetts
Beth Israel Desc. Med Ctr
Boston

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Minnesota
Mayo Clinic
Rochester

United States, Mississippi
Hattiesburg Clinic Hematology/Oncology
Hattiesburg

United States, Missouri
Local Institution
Saint Louis

United States, New York
Laura & Isaac Perlmutter Cancer Ctr at NYU Langone
New York

United States, New York
Laura and Isaac Perlmutter Cancer Center at Ambulatory Care Center
New York

United States, New York
Memorial Sloan Kettering Cancer Center
New York

United States, North Carolina
Levine Cancer Institute
Charlotte

United States, North Carolina
Local Institution
Durham

United States, Pennsylvania
Ann B. Barshinger Cancer Institute
Lancaster

United States, Pennsylvania
University Of Pennsylvania
Philadelphia

United States, Pennsylvania
Local Institution
Philadelphia

United States, Texas
MD Anderson Cancer Center
Houston

United States, Texas
Local Institution
Temple

United States, Wisconsin
University Of Wisconsin
Madison

Argentina, Buenos Aires
Local Institution
Capital Federal

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma Beunos Aires

Argentina, Distrito Federal
Local Institution - 0122
Buenos Aires

Argentina, Distrito Federal
Local Institution - 0120
Capital Federal

Argentina, Distrito Federal
Local Institution
Ciudad Autónoma de Buenos Aires

Argentina, RIO Negro
Local Institution
Viedma

Argentina, RIO Negro
Local Institution
Viedma

Argentina
Local Institution - 0119
Buenos Aires

Argentina
Local Institution
Caba

Argentina
Local Institution
Caba

Australia, New South Wales
Local Institution - 0044
Blacktown

Australia, Queensland
Local Institution
Herston

Australia, Queensland
Local Institution - 0043
Southport

Australia, South Australia
Local Institution - 0068
Elizabeth Vale

Australia, Victoria
Local Institution - 0055
Clayton

Australia, Victoria
Local Institution - 0069
Heidelberg

Belgium
Local Institution
Brussels

Belgium
Local Institution
Brussels

Belgium
Local Institution
Brussel

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Leuven

Belgium
Local Institution
Liège

Belgium
Local Institution
Woluwe-Saint-Lambert

Canada, Alberta
Local Institution
Edmonton

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution - 0070
Toronto

Canada, Ontario
Local Institution
Toronto

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution - 0077
Montréal

Canada
Local Institution - 0076
Ottawa

Canada
Local Institution
Quebec

Chile, Metropolitana
Local Institution - 0117
Santiago

Chile, Metropolitana
Local Institution - 0118
Santiago

Czechia
Local Institution
Brno

Czechia
Local Institution
Brno

Czechia
Local Institution - 0071
Brno

Czechia
Local Institution
Hradec Kralove

Czechia
Local Institution - 0073
Hradec Kralove

Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika
Olomouc

Germany
Local Institution
Cologne

Germany
Local Institution
Hamburg

Germany
Local Institution
Hannover

Germany
Local Institution
Heilbronn

Germany
Local Institution
Mannheim

Germany
Local Institution
Munich

Germany
Local Institution
Ulm

Germany
Local Institution
Wuerzburg

Italy
Local Institution
Catania

Italy
Local Institution
Milano

Italy
Local Institution - 0093
Milan

Italy
Local Institution
Modena

Italy
Local Institution - 0092
Padova

Italy
Local Institution
Padova

Italy
Local Institution - 0094
Rozzano

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Rostov-on-don

Spain
Local Institution - 0079
Badalona

Spain
Local Institution - 0052
Barcelona

Spain
Local Institution - 0114
Madrid

Spain
Local Institution - 0051
Madrid

Spain
Local Institution - 0115
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution - 0080
Pamplona

Spain
Local Institution - 0096
Sevilla

United Kingdom, Aberdeenshire
Local Institution
Aberdeen

United Kingdom, Avon
Local Institution
Bristol

United Kingdom, Greater London
Local Institution
London

United Kingdom, Greater London
Local Institution
London

United Kingdom
Local Institution
Coventry

United Kingdom
Local Institution
Manchester

United Kingdom
Local Institution
Surrey

Sponsors and Collaborators

Bristol-Myers Squibb

Novartis

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03377361 History of Changes
  • Other Study ID Numbers: CA209-9N9, 2017-001830-24
  • First Posted: December 19, 2017 Key Record Dates
  • Last Update Posted: June 14, 2022
  • Last Verified: June 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Digestive System Neoplasms
    Neoplasms by Site
    Neoplasms
    Digestive System Diseases
    Gastrointestinal Diseases
    Colonic Diseases
    Gastrointestinal Neoplasms
    Intestinal Diseases
    Rectal Diseases
    Colorectal Neoplasms
    Intestinal Neoplasms