Melanoma Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
| Verified date | June 2021 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | July 2, 2020 |
| Est. primary completion date | July 2, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 12 years and older unless not permitted by local regulations; in that case 18 years old and older - Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 - Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition) - Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma) - Measurable disease per RECIST v1.1 Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Uveal or ocular melanoma - Participants with active, known, or suspected autoimmune disease - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured Other protocol defined inclusion/exclusion criteria could apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution | Blacktown | New South Wales |
| Australia | Local Institution | Box Hill | Victoria |
| Australia | Local Institution | Greenslopes | Queensland |
| Australia | Local Institution | Melbourne | Victoria |
| Australia | Local Institution | Melbourne | Victoria |
| Australia | Melanoma Institute Australia | North Sydney | New South Wales |
| Australia | Local Institution | Woolloongabba | Queensland |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Quebec | |
| Czechia | Klinika onkologie a radioterapie | Hradec Kralove | |
| Czechia | Dermatovenerologicka klinika 3. LF UK a FNKV | Praha 10 | |
| Czechia | Dermatovenerologicka klinika VFN a 1. LF UK | Praha 2 | |
| France | Local Institution | Boulogne-billancourt | |
| France | Local Institution | Saint Etienne Cedex 2 | |
| France | Local Institution | Villejuif Cedex | |
| Germany | Elbe Klinikum Buxtehude | Buxtehude | |
| Germany | Universitaetsklinikum Carl Gustav Carus | Dresden | |
| Germany | Local Institution | Essen | |
| Germany | SRH Wald-Kliniken Gera GmbH | Gera | |
| Germany | Georg August Universitaet Goettingen | Goettingen | |
| Germany | Local Institution | Hannover | |
| Germany | Local Institution | Heidelberg | |
| Germany | Local Institution | Muenchen | |
| Germany | Local Institution | Tuebingen | |
| Greece | Interbalkan European Medical Center | Thessaloniki | |
| Ireland | Local Institution | Dooradoyle | Limerick |
| Ireland | Local Institution | Dublin | |
| Ireland | Local Institution | Dublin | |
| Italy | Local Institution | Milano | |
| Italy | Istituto Nazionale Tumori Fondazione Pascale | Napoli | |
| Italy | Azienda Ospedaliera Universitaria Senese | Siena | |
| Japan | Local Institution | Chuo-ku | Tokyo |
| Japan | Local Institution | Niigata-shi | Niigata |
| Japan | Local Institution | Okayama-shi | Okayama |
| Japan | Local Institution | Osaka-shi | Osaka |
| Japan | Local Institution | Sendai-shi | Miyagi |
| Netherlands | Local Institution | Amsterdam | |
| Netherlands | Local Institution | Groningen | |
| Netherlands | Local Institution | Nijmegen | |
| Netherlands | Local Institution | Rotterdam | |
| New Zealand | Local Institution | Christchurch | |
| New Zealand | Local Institution | Wellington | |
| Poland | Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow | Warszawa | |
| Spain | Local Institution | Barcelona | |
| Spain | Local Institution | Jaen | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Malaga | |
| Spain | Local Institution | Santiago Compostela | |
| Spain | Local Institution | Valencia | |
| Switzerland | Universitaetsspital Zuerich | Zürich | |
| United Kingdom | Local Institution | Belfast | |
| United Kingdom | Local Institution | Cambridge | |
| United Kingdom | Local Institution | Cottingham | |
| United Kingdom | Local Institution | London | Greater London |
| United Kingdom | Local Institution | London | Greater London |
| United Kingdom | Local Institution | Manchester | |
| United Kingdom | Local Institution | Tauton | |
| United States | University Of Colorado | Aurora | Colorado |
| United States | University Of Chicago | Chicago | Illinois |
| United States | Angeles Clinic and Research Institute | Los Angeles | California |
| United States | Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Local Institution | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Canada, Czechia, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events | Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation | From first dose to 30 days following last dose (up to approximately 25 months) |
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