NCT03377361 - Bristol Myers Squibb™

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

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

Contacts and Locations

Contacts

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

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, 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
Massachusetts General Hospital
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, New York
Laura & Isaac Perlmutter Cancer Ctr at NYU Langone
New York

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

United States, New York
Yale Cancer Center
New York

United States, North Carolina
Local Institution
Charlotte

United States, North Carolina
Local Institution
Durham

United States, Pennsylvania
University Of Pennsylvania
Philadelphia

United States, Texas
MD Anderson Cancer Center
Houston

United States, Wisconsin
University Of Wisconsin
Madison

Argentina, Buenos Aires
Local Institution
Capital Federal

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma Beunos Aires

Argentina, RIO Negro
Local Institution
Viedma

Argentina
Local Institution
Caba

Australia, New South Wales
Local Institution
Blacktown

Australia, Queensland
Local Institution
Herston

Australia, Queensland
Local Institution
Southport

Australia, South Australia
Local Institution
Elizabeth Vale

Australia, Victoria
Local Institution
Clayton

Australia, Victoria
Local Institution
Heidelberg

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
Woluwe-Saint-Lambert

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Canada
Local Institution
Quebec

Czechia
Local Institution
Brno

Czechia
Local Institution
Hradec Kralove

Czechia
Local Institution
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
Modena

Italy
Local Institution
Padova

Italy
Local Institution
Rozzano

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Rostov-on-don

Spain
Local Institution
Badalona

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Pamplona

Spain
Local Institution
Seville

United Kingdom, Aberdeenshire
Local Institution
Aberdeen

United Kingdom, Avon
Local Institution
Bristol

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: February 9, 2021
Last Verified: February 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms: Colorectal Neoplasms

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Condition Categories

Clinical Trials of Interest

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)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

Log In to Bolder Science

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Condition Categories

Clinical Trials of Interest

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)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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