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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03377361




Registration number
NCT03377361
Ethics application status
Date submitted
14/12/2017
Date registered
19/12/2017
Date last updated
19/08/2024

Titles & IDs
Public 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
Scientific title
A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
Secondary ID [1] 0 0
2017-001830-24
Secondary ID [2] 0 0
CA209-9N9
Universal Trial Number (UTN)
Trial acronym
CheckMate 9N9
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Colorectal Tumors 0 0
Colorectal Carcinoma 0 0
Colorectal Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Drugs - Trametinib
Treatment: Other - Ipilimumab
Treatment: Drugs - Regorafenib

Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib -

Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib -

Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib -

Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib -

Experimental: Part 2 Cohort 5 (3L): Regorafenib -

Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: Trametinib
Specified dose on specified days

Treatment: Other: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Regorafenib
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicity (DLTs)
Timepoint [1] 0 0
Up to 23 months
Primary outcome [2] 0 0
Incidence of Adverse Events (AEs)
Timepoint [2] 0 0
Approximately 100 months
Primary outcome [3] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Approximately 100 months
Primary outcome [4] 0 0
Incidence of Deaths
Timepoint [4] 0 0
Up to 100 months
Primary outcome [5] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [5] 0 0
Up to 77 months
Primary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [6] 0 0
Up to 77 months
Primary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [7] 0 0
Up to 77 months
Primary outcome [8] 0 0
Objective response rate (ORR) by investigator (Part 1B and Part 2)
Timepoint [8] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Objective response rate (ORR) (Part 1A and Part 1)
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Approximately 24 months
Secondary outcome [4] 0 0
Time to response (TTR)
Timepoint [4] 0 0
Approximately 24 months
Secondary outcome [5] 0 0
Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumors (RECIST) v1.1
Timepoint [5] 0 0
Approximately 24 months
Secondary outcome [6] 0 0
Best overall response (BOR)
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
Approximately 40 months
Secondary outcome [8] 0 0
Incidence of Adverse Events (AEs)
Timepoint [8] 0 0
Approximately 100 months
Secondary outcome [9] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Approximately 100 months
Secondary outcome [10] 0 0
Incidence of Deaths
Timepoint [10] 0 0
Up to 100 months
Secondary outcome [11] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [11] 0 0
Up to 77 months
Secondary outcome [12] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [12] 0 0
Up to 77 months
Secondary outcome [13] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [13] 0 0
Up to 77 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2024
Actual
Sample size
Target
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0044 - Blacktown
Recruitment hospital [2] 0 0
Local Institution - 0043 - Southport
Recruitment hospital [3] 0 0
Local Institution - 0068 - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - 0055 - Clayton
Recruitment hospital [5] 0 0
Local Institution - 0069 - Heidelberg
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
05112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
0 - Clayton
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Distrito Federal
Country [14] 0 0
Belgium
State/province [14] 0 0
Woluwe-Saint-Lambert
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
State/province [18] 0 0
Ottawa
Country [19] 0 0
Chile
State/province [19] 0 0
Metropolitana
Country [20] 0 0
Chile
State/province [20] 0 0
Región Metropolitana De Santiago
Country [21] 0 0
Czechia
State/province [21] 0 0
Olomoucký Kraj
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Czechia
State/province [23] 0 0
Hradec Kralove
Country [24] 0 0
Germany
State/province [24] 0 0
Hannover
Country [25] 0 0
Italy
State/province [25] 0 0
Catania
Country [26] 0 0
Italy
State/province [26] 0 0
Milan
Country [27] 0 0
Italy
State/province [27] 0 0
Padova
Country [28] 0 0
Italy
State/province [28] 0 0
Rozzano
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona [Barcelona]
Country [30] 0 0
Spain
State/province [30] 0 0
Navarra
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Spain
State/province [33] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novartis
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03377361