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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03377361




Registration number
NCT03377361
Ethics application status
Date submitted
14/12/2017
Date registered
19/12/2017
Date last updated
4/03/2024

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
Other interventions - Nivolumab
Treatment: Drugs - Trametinib
Other interventions - 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 -


Other interventions: Nivolumab
Specified dose on specified days

Treatment: Drugs: Trametinib
Specified dose on specified days

Other interventions: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Regorafenib
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
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/Phase 2
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
1/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/03/2024
Actual
Sample size
Target
232
Accrual to date
Final
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
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Pamplona
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03377361
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