Study of BMS-936558 vs. Dacarbazine in Untreated, Unresectable or Metastatic Melanoma (CheckMate 066)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721772
First received: November 2, 2012
Last updated: September 15, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated, unresectable or metastatic melanoma


Condition Intervention Phase
Melanoma
Biological: BMS-936558 (Nivolumab)
Biological: Placebo matching BMS-936558 (Nivolumab)
Drug: Dacarbazine
Drug: Placebo matching Dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine 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) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    OS is defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first

  • Objective Response Rate (ORR) [ Time Frame: Up to 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 arm

  • Programmed death-ligand 1 (PD-L1) expression as predictive biomarker [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PD-L1 expression as measured by the endpoint OS based on PD-L1 expression level

  • Health Related Quality of Life (HRQoL) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

    HRQoL as measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/QoL composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 scales in all randomized subjects;

    EORTC-QLQ-C30 = European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Core 30



Estimated Enrollment: 410
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: BMS-936558(Nivolumab) with Placebo matching Dacarbazine
BMS-936558 (Nivolumab) 3 mg/kg Solution for injection, Intravenous (IV), Every 2 weeks with Placebo matching Dacarbazine 0mg/m² Solution for injection, IV, Every 3 weeks, Until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: BMS-936558 (Nivolumab) Drug: Placebo matching Dacarbazine
Active Comparator: Arm B: Dacarbazine with Placebo matching BMS-936558(Nivolumab)
Dacarbazine 1000mg/m² Solution for injection, IV, Every 3 weeks with Placebo matching BMS-936558 (Nivolumab) 0 mg/kg Solution for injection, Intravenous (IV), Every 2 weeks, Until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Placebo matching BMS-936558 (Nivolumab) Drug: Dacarbazine

  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 of 0 or 1
  • Untreated, histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
  • Known BRAF wild-type as per regionally acceptable V600 mutational status testing. BRAF mutant subjects and those with indeterminate or unknown BRAF status are not permitted to randomize

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Any active, known or suspected autoimmune disease
  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: NCT01721772

  Hide Study Locations
Locations
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1425
Local Institution
Buenos Aires, Argentina, C1426ANZ
Local Institution
Cordoba, Argentina, 5000
Australia, New South Wales
Local Institution
Camperdown, New South Wales, Australia, 2050
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Coffs Harbour, New South Wales, Australia, 2450
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Local Institution
Greenslopes, Queensland, Australia, 4120
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Southport, Queensland, Australia, 4215
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Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Local Institution
Malvern, Victoria, Australia, 3144
Australia
Local Institution
North Sydney, Australia, 2060
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Bc Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Qe Ii Health Science Centre
Halfax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Mcgill University, Dept. Oncology
City, Quebec, Canada, H2W 1S6
Chile
Local Institution
Santiago, Metropolitana, Chile
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Vi?a Del Mar, Valparaiso, Chile
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Santiago, Chile, 7630370
Denmark
Local Institution
Aarhus, Denmark, 8000
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Herlev, Denmark, 2730
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Odense C, Denmark, 5000
Finland
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Helsinki, Finland, 00029
France
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Bordeaux, France, 33075
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Grenoble, France, 38043
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Lille, France, 59037
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Montpellier, France, 34295
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Paris, France, 75010
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Villejuif, France, 94805
Germany
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Wuerzburg, Bayern, Germany, 97080
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Essen, Germany, 45122
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Gera, Germany, 07548
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Goettingen, Germany, 37075
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Heidelberg, Germany, 69120
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Kiel, Germany, 24105
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Koeln, Germany, 50937
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Magdeburg, Germany, 39120
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Mainz, Germany, 55131
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Nuernberg, Germany, 90419
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Recklinghausen, Germany, 45657
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Tubingen, Germany, 72076
Greece
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Athens, Greece, 11527
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Neo Faliro, Greece, 18547
Israel
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Haifa, Israel, 34362
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Jerusalem, Israel, 91120
Local Institution
Tel Hashomer, Israel, 52621
Italy
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Bari, Italy, 70126
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Bergamo, Italy, 24127
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Genova, Italy, 16132
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Meldola (fc), Italy, 47014
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Milano, Italy, 20133
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Milano, Italy, 20141
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Roma, Italy, 00144
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Siena, Italy, 53100
Mexico
Local Institution
Tlalpan, Distrito Federal, Mexico, 14080
Local Institution
Leon, Guanajato, Guanajuato, Mexico, 37000
Local Institution
Morelia, Michoacan, Mexico
Local Institution
Mexico City, Mexico, CP 003310
Norway
Local Institution
Oslo, Norway, 0379
Poland
Local Institution
Gdansk, Poland, 80-219
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Lodz, Poland, 93-513
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Warszawa, Poland, 02-781
Spain
Local Institution
San Sebastian, Guipuzcoa, Spain, 20014
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Barcelona, Spain, 08036
Local Institution
Madrid, Spain, 28033
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Madrid, Spain, 28034
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Sevilla, Spain, 41009
Local Institution
Valencia, Spain, 46014
Sweden
Local Institution
Gothenberg, Sweden, 413 45
Local Institution
Lund, Sweden, 221 85
Local Institution
Umea, Sweden, 901 85
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: NCT01721772     History of Changes
Other Study ID Numbers: CA209-066, 2012‐003718‐16
Study First Received: November 2, 2012
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
Denmark: Danish Dataprotection Agency
Finland: Laakelaitos
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Data Inspectorate Directorate for Health and Social Affairs
Poland: National Institute of Medicines
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 15, 2014