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 #.

  Show 33 Study Locations
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 16, 2014