Study of BMS-936558 vs. Dacarbazine in Untreated, Unresectable or Metastatic Melanoma
This study is currently recruiting participants.
Verified April 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721772
First received: November 2, 2012
Last updated: April 8, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 (Anti-PD-1) Biological: Placebo matching BMS-936558 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: | June 2020 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A: BMS-936558 (Anti-PD-1) OR Placebo matching BMS-936558
BMS-936558 3 mg/kg (0mg/kg Placebo matching BMS-936558) Solution for injection, Intravenous (IV), Every 2 weeks Until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Biological: BMS-936558 (Anti-PD-1) Biological: Placebo matching BMS-936558 |
|
Active Comparator: Arm B: Dacarbazine OR Placebo matching Dacarbazine
Dacarbazine 1000mg/m² (0mg/m² Placebo matching Dacarbazine) Solution for injection, IV, Every 3 weeks Until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Drug: Dacarbazine Drug: Placebo matching Dacarbazine |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
- Recently acquired (within 90 days prior to randomization) 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 enroll
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Any active, known or suspected autoimmune disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721772
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Locations
| Argentina | |
| Local Institution | Not yet recruiting |
| Capital Federal, Buenos Aires, Argentina, 1425 | |
| Contact: Site 0025 | |
| Local Institution | Not yet recruiting |
| Capital Federal, Buenos Aires, Argentina, 1280 | |
| Contact: Site 0027 | |
| Local Institution | Not yet recruiting |
| Caba, Argentina, 1426 | |
| Contact: Site 0026 | |
| Australia, New South Wales | |
| Local Institution | Not yet recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Contact: Site 0002 | |
| Local Institution | Not yet recruiting |
| Coffs Harbour, New South Wales, Australia, 2450 | |
| Contact: Site 0069 | |
| Local Institution | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Site 0059 | |
| Australia, Queensland | |
| Local Institution | Not yet recruiting |
| Brisbane, Queensland, Australia, 4102 | |
| Contact: Site 0003 | |
| Local Institution | Recruiting |
| Greenslopes Qld, Queensland, Australia, 4102 | |
| Contact: Site 0019 | |
| Local Institution | Recruiting |
| Southport, Queensland, Australia, 4215 | |
| Contact: Site 0007 | |
| Australia, South Australia | |
| Local Institution | Not yet recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Site 0004 | |
| Australia | |
| Local Institution | Not yet recruiting |
| North Sydney, Australia, 2060 | |
| Contact: Site 0006 | |
| Chile | |
| Local Institution | Not yet recruiting |
| Santiago, Metropolitana, Chile | |
| Contact: Site 0029 | |
| Local Institution | Not yet recruiting |
| Vina Del Mar, Valparaiso, Chile, 254 0364 | |
| Contact: Site 0028 | |
| France | |
| Local Institution | Recruiting |
| Lille, Cedex, France, 59037 | |
| Contact: Site 0017 | |
| Local Institution | Recruiting |
| Bordeaux, France, 33075 | |
| Contact: Site 0014 | |
| Local Institution | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Site 0016 | |
| Local Institution | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Site 0018 | |
| Local Institution | Recruiting |
| Paris, France, 75010 | |
| Contact: Site 0015 | |
| Local Institution | Recruiting |
| Villejuif, France, 94800 | |
| Contact: Site 0013 | |
| Germany | |
| Local Institution | Not yet recruiting |
| Essen, Germany, 45122 | |
| Contact: Site 0052 | |
| Local Institution | Not yet recruiting |
| Gera, Germany, 07548 | |
| Contact: Site 0060 | |
| Local Institution | Not yet recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Site 0048 | |
| Local Institution | Not yet recruiting |
| Kiel, Germany, 24105 | |
| Contact: Site 0049 | |
| Local Institution | Not yet recruiting |
| Koln, Germany, 50931 | |
| Contact: Site 0046 | |
| Local Institution | Not yet recruiting |
| Mainz, Germany, 55101 | |
| Contact: Site 0051 | |
| Local Institution | Not yet recruiting |
| Regensburg, Germany, 93053 | |
| Contact: Site 0050 | |
| Local Institution | Not yet recruiting |
| Tubingen, Germany, 72076 | |
| Contact: Site 0047 | |
| Poland | |
| Local Institution | Suspended |
| Poznan, Poland, 60-693 | |
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: | April 8, 2013 |
| 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 May 21, 2013