A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer (CheckMate 142)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02060188
First received: December 18, 2013
Last updated: October 13, 2014
Last verified: May 2014

December 18, 2013
October 13, 2014
March 2014
December 2016   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
(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))
Same as current
Complete list of historical versions of study NCT02060188 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
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)
Same as current
Not Provided
Not Provided
 
A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer (CheckMate 142)
A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer

The purpose of this study is to examine if Nivolumab alone or in combination with Ipilimumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors.

Allocation: The Microsatellite Instability High (MSI-High) Part of the trial is Non-randomized, The Non-MSI high part of the trial contains a randomized portion

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • MSI Positive Colorectal Cancer
  • MSI Negative Colorectal Cancer
  • Drug: Ipilimumab
  • Drug: Nivolumab
    Other Name: BMS-936558
  • 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 + Ipilimumab

    Dose Escalation Phase:

    Dose Level -1: Nivolumab 0.3mg/Kg IV combined with Ipilimumab 1 mg/Kg IV every 3 weeks for 4 doses followed by Nivolumab 3mg/Kg IV every 2 weeks until disease progression

    Dose Level 1: Nivolumab 1mg/Kg IV combined with Ipilimumab 1 mg/Kg IV every 3 weeks for 4 doses followed by Nivolumab 3mg/Kg IV every 2 weeks until disease progression

    Dose Level 2a: Nivolumab 1mg/Kg IV combined with Ipilimumab 3 mg/Kg IV every 3 weeks for 4 doses followed by Nivolumab 3mg/Kg IV every 2 weeks until disease progression

    Dose Level 2b: Nivolumab 3mg/Kg IV combined with Ipilimumab 1 mg/Kg IV every 3 weeks for 4 doses followed by Nivolumab 3mg/Kg IV every 2 weeks until disease progression

    Interventions:
    • Drug: Ipilimumab
    • Drug: Nivolumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
July 2017
December 2016   (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 colorectal cancer
  • Measurable disease by CT or MRI
  • Testing for MSI Status
  • 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

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
Both
18 Years and older
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 #.
United States,   Belgium,   France,   Spain,   Italy,   Ireland,   Australia,   Canada
 
NCT02060188
CA209-142, 2013-003939-30
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

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