Clinical Trial - NCT02060188

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

Active, not recruiting

Sponsor: Bristol-Myers Squibb

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02060188

Protocol Info

Short Description: Phase 2 of Nivolumab +/- Ipilimumab in Rec. and Met. Colon Cancer (CheckMate 142)
Long Description: A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer
MGH Status: Closed
Sponsor: Bristol Myers Squibb
Disease Program: GI

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




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 Title Intervention Phase
Microsatellite Unstable Colorectal Cancer Microsatellite Stable Colorectal Cancer Mismatch Repair Proficient Colorectal Cancer Mismatch Repair Deficient Colorectal Cancer Ipilimumab Nivolumab Cobimetinib Daratumumab anti-LAG-3 antibody Phase 2
Study Type Interventional
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

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)] [Designated as safety issue: ]


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)] [Designated as safety issue: ]

Estimated Enrollment: 340
Study Start Date: March 2014
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022
Arms Assigned Interventions

Experimental:Nivolumab Monotherapy

Nivolumab administered as IV infusion at a dose of 3mg/kg every 2 weeks until disease progression

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

Experimental:Nivolumab (Nivo) + Ipilimumab (Ipi) Cohort C3

Nivo IV dosed every 2wk with Ipi IV dosed every 6wk.

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:Cobimetinib

Experimental:Nivolumab (Nivo) + BMS-986016 Cohort C5

Nivo IV dosed every 2wk with BMS-986016 dosed every 2 wk
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
Drug:Daratumumab

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

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

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 Farber 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
    • Westmead Hospital Westmead, New South Wales, Australia, 2145
  • Australia, Queensland
    • Tasman Oncology Research Pty Ltd Southport, Queensland, Australia, 4215
  • Australia, Victoria
    • Royal Melbourne Hospital 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, TO
    • Local Institution Candiolo, TO, Italy, 10060
  • Italy,
    • 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

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02060188
Other Study ID Numbers: 2013-003939-30
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Colorectal Neoplasms

Nivolumab

Ipilimumab

Daratumumab

Antibodies

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020