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

Colorectal Cancer Clinical Trial

— CheckMate 9N9  

Official title:

A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03377361
• Other study ID #: CA209-9N9
• Secondary ID: 2017-001830-24
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2018
• Est. completion date: March 11, 2024

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 232
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasm
• Colorectal Neoplasms
• Colorectal Tumors

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Drug:
• Trametinib
Specified dose on specified days

Biological:
• Ipilimumab
Specified dose on specified days

Drug:
• Regorafenib
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0119	Buenos Aires
Argentina	Local Institution - 0122	Buenos Aires	Distrito Federal
Argentina	Local Institution - 0120	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0123	Ciudad Autónoma de Buenos Aires	Distrito Federal
Australia	Local Institution - 0044	Blacktown	New South Wales
Australia	Local Institution - 0055	Clayton	Victoria
Australia	Local Institution - 0068	Elizabeth Vale	South Australia
Australia	Local Institution - 0069	Heidelberg	Victoria
Australia	Local Institution - 0043	Southport	Queensland
Belgium	Local Institution	Woluwe-Saint-Lambert
Canada	Local Institution - 0113	Edmonton	Alberta
Canada	Local Institution - 0077	Montréal	Quebec
Canada	Local Institution - 0076	Ottawa
Canada	Local Institution - 0070	Toronto	Ontario
Chile	Local Institution - 0117	Santiago	Metropolitana
Chile	Local Institution - 0118	Santiago	Región Metropolitana De Santiago
Czechia	Local Institution - 0071	Brno
Czechia	Local Institution - 0073	Hradec Kralove
Czechia	Local Institution - 0072	Olomouc	Olomoucký Kraj
Germany	Local Institution - 0004	Hannover
Italy	Local Institution - 0095	Catania
Italy	Local Institution - 0093	Milan
Italy	Local Institution - 0092	Padova
Italy	Local Institution - 0094	Rozzano
Spain	Local Institution - 0079	Badalona	Barcelona [Barcelona]
Spain	Local Institution - 0052	Barcelona
Spain	Local Institution - 0051	Madrid
Spain	Local Institution - 0114	Madrid
Spain	Local Institution - 0115	Madrid
Spain	Local Institution - 0080	Pamplona
Spain	Local Institution - 0096	Sevilla
United States	Local Institution - 0028	Baltimore	Maryland
United States	Local Institution - 0022	Birmingham	Alabama
United States	Local Institution - 0029	Charlotte	North Carolina
United States	Local Institution - 0107	Gainesville	Florida
United States	Local Institution - 0116	Hattiesburg	Mississippi
United States	Local Institution - 0100	Lancaster	Pennsylvania
United States	Local Institution - 0027	Los Angeles	California
United States	Local Institution - 0067	Los Angeles	California
United States	Local Institution - 0002	Madison	Wisconsin
United States	Local Institution - 0111	Miami	Florida
United States	Local Institution - 0104	New York	New York
United States	Local Institution - 0003	Philadelphia	Pennsylvania
United States	Thomas Jefferson University - Clinical Research Institute	Philadelphia	Pennsylvania
United States	Local Institution - 0103	Saint Louis	Missouri
United States	Local Institution - 0001	San Francisco	California
United States	Local Institution - 0101	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Novartis

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  Czechia,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicity (DLTs)		Up to 23 months
Primary	Incidence of Adverse Events (AEs)		Approximately 100 months
Primary	Incidence of Serious Adverse Events (SAEs)		Approximately 100 months
Primary	Incidence of Deaths		Up to 100 months
Primary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 77 months
Primary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 77 months
Primary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 77 months
Primary	Objective response rate (ORR) by investigator (Part 1B and Part 2)		Approximately 24 months
Secondary	Objective response rate (ORR) (Part 1A and Part 1)		Approximately 24 months
Secondary	Disease control rate (DCR)		Approximately 24 months
Secondary	Duration of response (DOR)		Approximately 24 months
Secondary	Time to response (TTR)		Approximately 24 months
Secondary	Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumors (RECIST) v1.1		Approximately 24 months
Secondary	Best overall response (BOR)		Up to 24 months
Secondary	Overall survival (OS)		Approximately 40 months
Secondary	Incidence of Adverse Events (AEs)		Approximately 100 months
Secondary	Incidence of Serious Adverse Events (SAEs)		Approximately 100 months
Secondary	Incidence of Deaths		Up to 100 months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 77 months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 77 months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 77 months

External Links

•   BMS Clinical Trial Information