Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01844505
First received: April 29, 2013
Last updated: October 13, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.


Condition Intervention Phase
Unresectable or Metastatic Melanoma
Biological: Nivolumab
Biological: Ipilimumab
Biological: Placebo for Nivolumab
Biological: Placebo for Ipilimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Endpoint of Overall Survival (OS) in all randomized subjects [ Time Frame: Approximately up to 44.1 months ] [ Designated as safety issue: No ]
    OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. OS data will be collected continuously while subjects are on study medication and every 3 months via in-person or phone contact after discontinuation of study medication

  • Progress Free Survival (PFS) [ Time Frame: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ] [ Designated as safety issue: No ]
    PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Baseline (Day 1), Week 12 every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
    ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of randomized subjects for each treatment group. The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first

  • Differences in OS, PFS, and ORR between the two experimental arms [ Time Frame: OS: Approximately up to 44.1 months; PFS and OOR: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ] [ Designated as safety issue: No ]
  • OS based on PD-L1 expression [ Time Frame: Baseline (Day 1) ] [ Designated as safety issue: No ]
  • Mean changes from baseline in EORTC-QLQ-C30 [ Time Frame: Day 1 of Week 1, Day 1 of Week 5 and Follow up visits 1 and 2 ] [ Designated as safety issue: No ]
    European Organisation for Research and Treatment of Care Quality of Life Questionnaire (EORTC QLQ) C-30 global health status/QoL composite scale data and the remaining EORTC QLQ C-30 scale data will be summarized by timepoint using descriptive statistics for each treatment group


Estimated Enrollment: 915
Study Start Date: May 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Biological: Placebo for Nivolumab Biological: Placebo for Ipilimumab
Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab
Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010
Biological: Placebo for Nivolumab
Experimental: Arm C: Ipilimumab+Placebo for Nivolumab
Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010
Biological: Placebo for Nivolumab

  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:

  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment naïve patients
  • Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
  • Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Subjects with active, known or suspected autoimmune disease
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
  • Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
  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: NCT01844505

  Show 157 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: NCT01844505     History of Changes
Other Study ID Numbers: CA209-067, 2012-005371-13
Study First Received: April 29, 2013
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
New Zealand: Medsafe
Canada: Health Canada
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health
Brazil: Ethics Committee
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Turkey: Ministry of Health
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health
Switzerland: Federal Office of Public Health
Switzerland: Swissmedic
France: Agence Nationale de Sécurité du Médicament et des produits de santé
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Finland: Finnish Medicines Agency
Finland: Data Protection Board
Finland: National Advisory Board on Health Care Ethics
Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Institutional Review Board
Sweden: Swedish National Council on Medical Ethics
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Ireland: Irish Medicines Board
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
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

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014