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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 (CheckMate142)

This study is currently recruiting participants.
Verified September 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02060188
First Posted: February 11, 2014
Last Update Posted: September 18, 2017
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
December 18, 2013
February 11, 2014
September 18, 2017
March 7, 2014
March 11, 2018   (Final data collection date for primary outcome measure)
Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators [ Time Frame: 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) ]
(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))
Objective response rate (ORR) in all MSI-High subjects as determined by Investigators [ Time Frame: 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) ]
(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))
Complete list of historical versions of study NCT02060188 on ClinicalTrials.gov Archive Site
ORR in all MSI-H and non-MSI-H subjects based on IRRC determination [ Time Frame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) ]
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)
ORR in all MSI-H subjects based on IRRC determination [ Time Frame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) ]
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)
Not Provided
Not Provided
 
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
A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite High (MSI-H) and Non-MSI-H Colon Cancer
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.
Allocation: The Microsatellite Instability High (MSI-High) and C4 and C6 Cohort Parts of the trial are Non-randomized, The Non-MSI high Dose Escalation Phase part of the trial contained a randomized portion
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Microsatellite Unstable Colorectal Cancer
  • Microsatellite Stable Colorectal Cancer
  • Mismatch Repair Proficient Colorectal Cancer
  • Mismatch Repair Deficient Colorectal Cancer
  • Drug: Ipilimumab
    Other Name: Yervoy
  • Drug: Nivolumab
    Other Names:
    • BMS-936558
    • Opdivo
  • Drug: Cobimetinib
    Other Name: Cotellic
  • Drug: Daratumumab
    Other Name: Darzalex
  • Drug: anti-LAG-3 antibody
    Other Name: BMS-986016
  • Experimental: Nivolumab Monotherapy
    Nivolumab administered as IV infusion at a dose of 3mg/kg every 2 weeks until disease progression
    Intervention: Drug: Nivolumab
  • 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
    Interventions:
    • Drug: Ipilimumab
    • Drug: Nivolumab
  • Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) Cohort C3
    Nivo IV dosed every 2wk with Ipi IV dosed every 6wk.
    Interventions:
    • Drug: Ipilimumab
    • Drug: Nivolumab
  • 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.
    Interventions:
    • Drug: Ipilimumab
    • Drug: Nivolumab
    • Drug: Cobimetinib
  • Experimental: Nivolumab (Nivo) + BMS-986016 Cohort C5
    Nivo IV dosed every 2wk with BMS-986016 dosed every 2 wk
    Interventions:
    • Drug: Nivolumab
    • Drug: anti-LAG-3 antibody
  • 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
    Interventions:
    • Drug: Nivolumab
    • Drug: Daratumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
December 31, 2019
March 11, 2018   (Final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
Australia,   Belgium,   Canada,   France,   Ireland,   Italy,   Spain,   United States
 
 
NCT02060188
CA209-142
2013-003939-30 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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