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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.
See Contacts and Locations
Verified June 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02060188
First received: December 18, 2013
Last updated: June 26, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Microsatellite Unstable Colorectal Cancer Microsatellite Stable Colorectal Cancer Mismatch Repair Proficient Colorectal Cancer Mismatch Repair Deficient Colorectal Cancer Drug: Ipilimumab Drug: Nivolumab Drug: Cobimetinib Drug: Daratumumab Drug: anti-LAG-3 antibody Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

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 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))


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 340
Actual Study Start Date: March 7, 2014
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: March 11, 2018 (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 Names:
  • BMS-936558
  • Opdivo
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
Drug: Ipilimumab
Other Name: Yervoy
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) Cohort C3
Nivo IV dosed every 2wk with Ipi IV dosed every 6wk.
Drug: Ipilimumab
Other Name: Yervoy
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
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.
Drug: Ipilimumab
Other Name: Yervoy
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Drug: Cobimetinib
Other Name: Cotellic
Experimental: Nivolumab (Nivo) + BMS-986016 Cohort C5
Nivo IV dosed every 2wk with BMS-986016 dosed every 2 wk
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Drug: anti-LAG-3 antibody
Other Name: BMS-986016
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
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Drug: Daratumumab
Other Name: Darzalex

Detailed Description:
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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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

  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
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Tomislav Dragovich, Site 0028    480-256-3429      
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
Dana Faber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeffrey Clark, Site 0036    617-632-5960      
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeffrey Clark, Site 0002    617-724-9347      
United States, Minnesota
Allina Health System Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Joseph Leach, Site 0034    612-863-5658      
United States, North Carolina
Duke University Office of Research Administration 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 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    503-215-2855      
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Usman Shah, Site 0041    610-402-9543      
University Of Pittsburgh Cancer Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: James Lee, Site 0013    412-623-2677      
United States, Tennessee
Vanderbilt University Med Ctr Recruiting
Nashville, Tennessee, United States, 37232-0021
Contact: Emily Chan, Site 0006    615-936-5847      
United States, Texas
Md Anderson Can Cnt Recruiting
Houston, Texas, United States, 77030-4009
Contact: Michael Overman, Site 0003    713-563-7757      
Australia, New South Wales
Local Institution Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Site 0038         
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0040         
Australia, Queensland
Tasman Oncology Research Pty Ltd Recruiting
Southport, Queensland, Australia, 4215
Contact: , Site 0039    +61411518959      
Australia, Victoria
Local Institution Recruiting
Parkville, Victoria, Australia, 3050
Contact: Site 0037         
Belgium
Local Institution Recruiting
Brussels, Belgium, 1000
Contact: Site 0019         
Local Institution Recruiting
Brussels, Belgium, 1090
Contact: Site 0018         
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 0020         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Michael Sawyer, Site 0027         
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Albiruni Razak, Site 0016    4169464501      
France
Local Institution Recruiting
Paris, France, 75012
Contact: Site 0025         
Ireland
Local Institution Recruiting
Dublin 4, Ireland
Contact: Site 0022         
Local Institution Recruiting
Dublin 9, Ireland
Contact: Site 0023         
Local Institution Recruiting
Galway, Ireland
Contact: Site 0033         
Italy
Local Institution Recruiting
Candiolo, TO, Italy, 10060
Contact: Site 0030         
Local Institution Recruiting
Modena, Italy, 41124
Contact: Site 0035         
Local Institution Recruiting
Padova, Italy, Padova
Contact: Site 0032         
Spain
Local Institution Recruiting
Madrid, Spain, 28009
Contact: Site 0012         
Local Institution Recruiting
Madrid, Spain, 28050
Contact: Site 0010         
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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02060188     History of Changes
Other Study ID Numbers: CA209-142
2013-003939-30 ( EudraCT Number )
Study First Received: December 18, 2013
Last Updated: June 26, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies
Antibodies, Monoclonal
Nivolumab
Daratumumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 21, 2017