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: September 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
MSI Positive Colorectal Cancer
MSI Negative Colorectal Cancer
Drug: Ipilimumab
Drug: Nivolumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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))


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 96
Study Start Date: March 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab Monotherapy
Nivolumab administered as IV infusion at a dose of 3mg/kg every 2 weeks until disease progression
Drug: Nivolumab
Other Name: BMS-936558
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

Drug: Ipilimumab Drug: Nivolumab
Other Name: BMS-936558

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060188

Contacts
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 #.

  Hide Study Locations
Locations
United States, Arizona
Local Institution Not yet recruiting
Gilbert, Arizona, United States, 85234
Contact: Site 0028         
United States, California
Usc Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Heinz-Josef Lenz, Site 0004    323-865-0820      
Pacific Hematology Oncology Associates Recruiting
San Francisco, California, United States, 94115
Contact: Ari Baron, Site 0001    415-600-1775      
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bassel El-Rayes, Site 0008    404-778-1900      
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eunice Kwak, Site 0002    617-724-9347      
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eunice Kwak, Site 0036         
United States, Minnesota
Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Joseph Leach, Site 0034    612-863-5658      
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 11065
Contact: Site 0009         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Morse, Site 0024    919-668-1861      
Novant Health Oncology Specialists Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Franklin L Chen, Site 0029    336-718-8461      
United States, Oregon
Providence Cancer Center Oncology And Hematology Care- Eastside Recruiting
Portland, Oregon, United States, 97213
Contact: Todd Crocenzi, Site 0005    503-215-2492      
United States, Pennsylvania
Upmc Cancer Pavilion Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: James Lee, Site 0013    412-647-8205      
United States, Tennessee
Vanderbilt-Ingram Cancer Ctr Recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily Chan, Site 0006    615-936-5847      
United States, Texas
The University Of Texas Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Michael Overman, Site 0003    713-563-7757      
Australia, New South Wales
Local Institution Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0040         
Australia, Queensland
Local Institution Not yet recruiting
Southport, Queensland, Australia, 4215
Contact: Site 0039         
Australia, Victoria
Local Institution Not yet recruiting
Parkville, Victoria, Australia, 3050
Contact: Site 0037         
Belgium
Local Institution Active, not recruiting
Brussels, Belgium, 1090
Local Institution Active, not recruiting
Brussels, Belgium, 1000
Local Institution Active, not recruiting
Leuven, Belgium, 3000
Canada, Alberta
Local Institution Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0027         
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Albiruni Razak, Site 0016    416-946-4501      
France
Local Institution Recruiting
Montpellier Cedex 05, France, 34298
Contact: Site 0026         
Local Institution Recruiting
Paris, France, 75012
Contact: Site 0025         
Ireland
Local Institution Active, not recruiting
Dublin 9, Dublin, Ireland
Local Institution Active, not recruiting
Dublin, Ireland, DUBLIN4
Local Institution Recruiting
Galway, Ireland
Contact: Site 0033         
Italy
Local Institution Recruiting
Candiolo, TO, Italy, 10060
Contact: Site 0030         
Local Institution Not yet recruiting
Modena, Italy, 41124
Contact: Site 0035         
Local Institution Recruiting
Padova, Italy, Padova
Contact: Site 0032         
Spain
Local Institution Recruiting
Madrid, Spain, 28050
Contact: Site 0010         
Local Institution Recruiting
Madrid, Spain, 28009
Contact: Site 0012         
Local Institution Recruiting
Sevilla, Spain, 41013
Contact: Site 0011         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02060188     History of Changes
Other Study ID Numbers: CA209-142, 2013-003939-30
Study First Received: December 18, 2013
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 30, 2014