The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02060188




Registration number
NCT02060188
Ethics application status
Date submitted
18/12/2013
Date registered
11/02/2014
Date last updated
6/11/2019

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab, and Nivolumab in Combination With Other Anti-cancer Drugs, 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 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
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Nivolumab
Treatment: Drugs - Cobimetinib
Treatment: Drugs - Daratumumab
Treatment: Drugs - anti-LAG-3 antibody

Experimental: Nivolumab Monotherapy - Nivolumab administered as IV infusion at a dose of 3mg/kg every 2 weeks until disease progression

Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) - Nivo 3mg/Kg IV with Ipi 1 mg/Kg IV every 3 week (wk) for 4 doses followed by Nivo 3mg/Kg IV every 2wk until progression
Dose Escalation Phase: (Complete)
Dose Level (DL) 1: Nivo 0.3mg/Kg with Ipi 1 mg/Kg IV every 3wk for 4 doses followed by Nivo 3mg/Kg IV every 2wk until progression
DL 1: Nivo 1mg/Kg IV with Ipi 1 mg/Kg IV every 3 wk for 4 doses followed by Nivo 3mg/Kg IV every 2wk until progression
DL 2a: Nivo 1mg/Kg IV with Ipi 3 mg/Kg IV every 3wk for 4 doses followed by Nivo 3mg/Kg IV every 2 wk until progression
DL 2b: Nivo 3mg/Kg IV with Ipi 1 mg/Kg IV every 3wk for 4 doses followed by Nivo 3mg/Kg IV every 2 wk until progression

Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) Cohort C3 - Nivo IV dosed every 2wk with Ipi IV dosed every 6wk.

Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) + Cobimetinib Cohort C4 - Nivo IV dosed every 2wk, with Ipi IV dosed every 6wk, combined with Cobimetinib dosed orally once daily 21 days on/7 days off.

Experimental: Nivolumab (Nivo) + BMS-986016 Cohort C5 - Nivo IV dosed every 2wk with BMS-986016 dosed every 2 wk

Experimental: Nivolumab (Nivo) + Daratumumab Cohort C6 - Daratumumab IV dosed weekly for week 1-8; then every 2 wks from Week 9-24; then every 4 wks on week 25; with Nivo dosed every 2 wks starting at week 3 and every 4 wks starting at week 25


Treatment: Drugs: Ipilimumab


Treatment: Drugs: Nivolumab


Treatment: Drugs: Cobimetinib


Treatment: Drugs: Daratumumab


Treatment: Drugs: anti-LAG-3 antibody


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators - (Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/-1 wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued (whichever occurs later)) (Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/-1 wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued (whichever occurs later))
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 in all MSI-H and non-MSI-H subjects based on IRRC determination - Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/- wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued(whichever occurs later)
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
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Men and women = 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

- Histologically confirmed recurrent or metastatic colorectal cancer

- Measurable disease by CT or MRI

- Testing for MSI Status (by an accredited lab)

1. Subjects with microsatellite instability high (MSI-H) tumors will enroll in the
MSI-H Cohort (mStage and cStage groups), the C3 Cohort, and the C5 Cohort.

2. Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H)
will enroll in the non- MSI-H Safety Cohort and the C6, C4 Cohorts.

- Adequate organ function as defined by study-specific laboratory tests

- Must use acceptable form of birth control throughout the study. After the final dose
of study drug, an acceptable form of birth control must be used for 23 weeks for women
of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with
WOCBP

- Signed informed consent

- Willing and able to comply with study procedures

- Subjects enrolled into the C3 Cohort must have not had treatment for their metastatic
disease
Minimum age
18 Years
Maximum age
No limit
Gender
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

- Subjects with active, known or suspected autoimmune disease

- Subjects 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 could 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Tasman Oncology Research Pty Ltd - Southport
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3050 - Parkville
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
TO
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 patients
with colon cancer that has come back or has spread, and who have a specific biomarker in
their tumors.
Trial website
https://clinicaltrials.gov/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
Other publications