Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
NCT ID: NCT01721772
Last Updated: 2022-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
418 participants
INTERVENTIONAL
2013-01-18
2021-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nivolumab, 3 mg/kg
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
BMS-936558 (Nivolumab)
Placebo matching Dacarbazine
Dacarbazine, 1000 mg/m^2
Participants received dacarbazine, 1000 mg/m\^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Placebo matching BMS-936558 (Nivolumab)
Dacarbazine
Interventions
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BMS-936558 (Nivolumab)
Placebo matching BMS-936558 (Nivolumab)
Dacarbazine
Placebo matching Dacarbazine
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
* Measurable disease as per Response Evaluation Criteria in Solid Tumors 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 patients and those with indeterminate or unknown BRAF status are not permitted to randomize
Exclusion Criteria
* Ocular melanoma
* Any active, known, or suspected autoimmune disease
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Fundacion Cidea
Buenos Aires, Distrito Federal, Argentina
Instituto Medico Especialazado Alexander Fleming
Buenos Aires, , Argentina
Instituto Oncologico De Cordoba
Córdoba, , Argentina
Local Institution
Camperdown, New South Wales, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Local Institution - 0006
North Sydney, New South Wales, Australia
Local Institution
Westmead, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Local Institution
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Local Institution - 0039
Vancouver, British Columbia, Canada
Qe Ii Health Science Centre
Halfax, Nova Scotia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Local Institution - 0040
Montreal, Quebec, Canada
Local Institution
Viña del Mar, Región de Valparaíso, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Santiago, , Chile
Aarhus Universitetshospital
Aarhus, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Local Institution - 0035
Helsinki, , Finland
Hopital Saint Andre
Bordeaux, , France
Chu Grenoble - Hopital Albert Michallon
Grenoble, , France
Chru De Lille - Hopital Claude Huriez
Lille, , France
Hopital St Eloi
Montpellier, , France
Hopital Saint Louis
Paris, , France
Local Institution - 0013
Villejuif, , France
Local Institution
Würzburg, Bavaria, Germany
Local Institution
Cologne, , Germany
Local Institution
Essen, , Germany
Local Institution
Gera, , Germany
Local Institution
Göttingen, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Kiel, , Germany
Local Institution
Magdeburg, , Germany
Local Institution
Mainz, , Germany
Local Institution
Nuremberg, , Germany
Local Institution
Recklinghausen, , Germany
Local Institution
Tübingen, , Germany
Laiko Hospital
Athens, , Greece
Metropolitan Hospital
Neo Faliro, , Greece
Local Institution
Haifa, , Israel
Local Institution
Jerusalem, , Israel
Local Institution
Tel Litwinsky, , Israel
Local Institution
Bari, , Italy
Local Institution
Bergamo, , Italy
Local Institution
Genova, , Italy
Local Institution
Meldola (fc), , Italy
Local Institution
Milan, , Italy
Local Institution
Milan, , Italy
Local Institution
Napoli, , Italy
Local Institution
Padua, , Italy
Local Institution
Roma, , Italy
Local Institution
Siena, , Italy
Local Institution
Leon, Guanajato, Guanajuato, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Tlalpan, Mexico City, Mexico
Local Institution
Morelia, Michoacán, Mexico
Local Institution
Oslo, , Norway
Local Institution
Gdansk, , Poland
Local Institution
Lodz, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Donostia / San Sebastian, Guipuzcoa, Spain
Local Institution - 0056
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Seville, , Spain
Local Institution
Valencia, , Spain
Local Institution
Gothenberg, , Sweden
Local Institution
Lund, , Sweden
Local Institution
Umeå, , Sweden
Countries
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References
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Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.
Robert C, Long GV, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Rutkowski P, Hassel JC, McNeil CM, Kalinka EA, Lebbe C, Charles J, Hernberg MM, Savage KJ, Chiarion-Sileni V, Mihalcioiu C, Mauch C, Arance A, Cognetti F, Ny L, Schmidt H, Schadendorf D, Gogas H, Zoco J, Re S, Ascierto PA, Atkinson V. Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma. J Clin Oncol. 2020 Nov 20;38(33):3937-3946. doi: 10.1200/JCO.20.00995. Epub 2020 Sep 30.
Ascierto PA, Long GV, Robert C, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbe C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Ny L, Arance A, Svane IM, Schadendorf D, Gogas H, Saci A, Jiang J, Rizzo J, Atkinson V. Survival Outcomes in Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma Treated With Nivolumab Therapy: Three-Year Follow-up of a Randomized Phase 3 Trial. JAMA Oncol. 2019 Feb 1;5(2):187-194. doi: 10.1001/jamaoncol.2018.4514.
Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.
Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Marquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.
Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbe C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Arance A, Schmidt H, Schadendorf D, Gogas H, Lundgren-Eriksson L, Horak C, Sharkey B, Waxman IM, Atkinson V, Ascierto PA. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015 Jan 22;372(4):320-30. doi: 10.1056/NEJMoa1412082. Epub 2014 Nov 16.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2012-003718-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-066
Identifier Type: -
Identifier Source: org_study_id
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