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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)

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ClinicalTrials.gov Identifier: NCT02060188
Recruitment Status : Active, not recruiting
First Posted : February 11, 2014
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment 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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : March 7, 2014
Estimated Primary Completion Date : December 3, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060188


  Hide Study Locations
Locations
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
Allina Health System
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Duke University Office of Research Administration
Durham, North Carolina, United States, 27710
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Providence Cancer Center Oncology and Hematology Care- Eastside
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
University Of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt University Med Ctr
Nashville, Tennessee, United States, 37232-0021
United States, Texas
Md Anderson Can Cnt
Houston, Texas, United States, 77030-4009
Australia, New South Wales
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Tasman Oncology Research Pty Ltd
Southport, Queensland, Australia, 4215
Australia, Victoria
Local Institution
Parkville, Victoria, Australia, 3050
Belgium
Local Institution
Brussels, Belgium, 1000
Local Institution
Brussels, Belgium, 1090
Local Institution
Leuven, Belgium, 3000
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 1X5
France
Local Institution
Paris, France, 75012
Ireland
Local Institution
Dublin 4, Ireland
Local Institution
Dublin 9, Ireland
Local Institution
Galway, Ireland
Italy
Local Institution
Candiolo, TO, Italy, 10060
Local Institution
Modena, Italy, 41124
Local Institution
Padova, Italy, Padova
Spain
Local Institution
Madrid, Spain, 28009
Local Institution
Madrid, Spain, 28050
Local Institution
Sevilla, Spain, 41013
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02060188     History of Changes
Other Study ID Numbers: CA209-142
2013-003939-30 ( EudraCT Number )
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

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