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: July 23, 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: November 2015
Estimated Primary Completion Date: September 2015 (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

  Show 75 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: NCT01721772     History of Changes
Other Study ID Numbers: CA209-066, 2012‐003718‐16
Study First Received: November 2, 2012
Last Updated: July 23, 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 July 24, 2014