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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/NCT02060188




Registration number
NCT02060188
Ethics application status
Date submitted
18/12/2013
Date registered
11/02/2014
Date last updated
10/05/2024

Titles & IDs
Public title
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
Scientific title
A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
Secondary ID [1] 0 0
2013-003939-30
Secondary ID [2] 0 0
CA209-142
Universal Trial Number (UTN)
Trial acronym
CheckMate142
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microsatellite Unstable Colorectal Cancer 0 0
Microsatellite Stable Colorectal Cancer 0 0
Mismatch Repair Proficient Colorectal Cancer 0 0
Mismatch Repair Deficient Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Nivolumab
Treatment: Drugs - Cobimetinib
Treatment: Drugs - Daratumumab
Treatment: Drugs - BMS-986016

Experimental: Nivolumab Monotherapy -

Experimental: Nivolumab + Ipilimumab -

Experimental: Nivolumab + Ipilimumab Cohort C3 -

Experimental: Nivolumab + Ipilimumab + Cobimetinib Cohort C4 -

Experimental: Nivolumab + BMS-986016 Cohort C5 -

Experimental: Nivolumab + Daratumumab Cohort C6 -


Treatment: Drugs: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Cobimetinib
Specified dose on specified days

Treatment: Drugs: Daratumumab
Specified dose on specified days

Treatment: Drugs: BMS-986016
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Timepoint [1] 0 0
The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (Approximately up to 34 months)
Secondary outcome [1] 0 0
ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC)
Timepoint [1] 0 0
The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months)

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Histologically confirmed recurrent or metastatic colorectal cancer

- Measurable disease per RECIST v1.1

- Microsatellite instability expression detected by an accredited laboratory

- Participants enrolled into the C3 Cohort must have not had treatment for their
metastatic disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active brain metastases or leptomeningeal metastases are not allowed

- Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2,
anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or
drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

- Prior malignancy active within the previous 3 years except for locally curable cancers

- Participants with active, known or suspected autoimmune disease

- Participants with a condition requiring systemic treatment with either corticosteroids
or other immunosuppressive medications within 14 days of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 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
12/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
Accrual to date
Final
385
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0040 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 0039 - Southport
Recruitment hospital [3] 0 0
Local Institution - 0037 - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
Ireland
State/province [16] 0 0
Dublin 4
Country [17] 0 0
Ireland
State/province [17] 0 0
Dublin 9
Country [18] 0 0
Ireland
State/province [18] 0 0
Galway
Country [19] 0 0
Italy
State/province [19] 0 0
Candiolo, Torino
Country [20] 0 0
Italy
State/province [20] 0 0
Modena
Country [21] 0 0
Italy
State/province [21] 0 0
Padova
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination
with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants
with colon cancer that has come back or has spread, and who have a specific biomarker in
their tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02060188
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02060188