Clinical trial NCT01721772: Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
Official title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-11-06
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma


Eligibility 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 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:

* Active brain metastases or leptomeningeal metastases
* Ocular melanoma
* Any active, known, or suspected autoimmune disease

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
measure: Overall Survival (OS) Rate
timeFrame: From randomization to 6 months and or to 12 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From date of randomization up to date of disease progression or death, up to approximately 84 months
measure: Progression-free Survival (PFS) Rate
timeFrame: From randomization to the specified timepoints, up to 84 months
measure: Objective Response Rate (ORR)
timeFrame: Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months
measure: Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
timeFrame: From date of randomization to date of disease progression or death, up to approximately 94 months
measure: Change From Baseline in Health-related Quality of Life (HRQoL) Scores
timeFrame: At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
state: Distrito Federal
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especialazado Alexander Fleming
city: Cordoba
country: Argentina
facility: Instituto Oncologico De Cordoba
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: North Sydney
country: Australia
facility: Local Institution - 0006
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Southport
country: Australia
facility: Local Institution
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0039
state: British Columbia
city: Halfax
country: Canada
facility: Qe Ii Health Science Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0040
state: Quebec
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Viña Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Santiago
country: Chile
facility: Local Institution
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: Local Institution - 0035
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Grenoble
country: France
facility: Chu Grenoble - Hopital Albert Michallon
city: Lille
country: France
facility: Chru De Lille - Hopital Claude Huriez
city: Montpellier
country: France
facility: Hopital St Eloi
city: Paris
country: France
facility: Hopital Saint Louis
city: Villejuif
country: France
facility: Local Institution - 0013
city: Wuerzburg
country: Germany
facility: Local Institution
state: Bayern
city: Essen
country: Germany
facility: Local Institution
city: Gera
country: Germany
facility: Local Institution
city: Goettingen
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Koeln
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Nuernberg
country: Germany
facility: Local Institution
city: Recklinghausen
country: Germany
facility: Local Institution
city: Tubingen
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Laiko Hospital
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Tel Hashomer
country: Israel
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Meldola (fc)
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Tlalpan
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Leon, Guanajato
country: Mexico
facility: Local Institution
state: Guanajuato
city: Morelia
country: Mexico
facility: Local Institution
state: Michoacan
city: Oslo
country: Norway
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: San Sebastian
country: Spain
facility: Local Institution
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Local Institution - 0056
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Gothenberg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Umea
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.