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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01721772




Registration number
NCT01721772
Ethics application status
Date submitted
2/11/2012
Date registered
6/11/2012
Date last updated
12/07/2022

Titles & IDs
Public title
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
Scientific title
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
2012-003718-16
Secondary ID [2] 0 0
CA209-066
Universal Trial Number (UTN)
Trial acronym
CheckMate 066
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 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.

Active comparator: 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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
Overall Survival (OS) Rate
Timepoint [2] 0 0
From randomization to 6 months and or to 12 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
From date of randomization up to date of disease progression or death, up to approximately 84 months
Secondary outcome [2] 0 0
Progression-free Survival (PFS) Rate
Timepoint [2] 0 0
From randomization to the specified timepoints, up to 84 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
Timepoint [4] 0 0
From date of randomization to date of disease progression or death, up to approximately 94 months
Secondary outcome [5] 0 0
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Timepoint [5] 0 0
At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active brain metastases or leptomeningeal metastases
* Ocular melanoma
* Any active, known, or suspected autoimmune disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2021
Sample size
Target
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
Local Institution - 0006 - North Sydney
Recruitment hospital [4] 0 0
Local Institution - Westmead
Recruitment hospital [5] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [6] 0 0
Local Institution - Southport
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2060 - North Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Distrito Federal
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Chile
State/province [9] 0 0
Metropolitana
Country [10] 0 0
Chile
State/province [10] 0 0
Valparaiso
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
Denmark
State/province [12] 0 0
Aarhus
Country [13] 0 0
Denmark
State/province [13] 0 0
Herlev
Country [14] 0 0
Denmark
State/province [14] 0 0
Odense
Country [15] 0 0
Finland
State/province [15] 0 0
Helsinki
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Grenoble
Country [18] 0 0
France
State/province [18] 0 0
Lille
Country [19] 0 0
France
State/province [19] 0 0
Montpellier
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Villejuif
Country [22] 0 0
Germany
State/province [22] 0 0
Bayern
Country [23] 0 0
Germany
State/province [23] 0 0
Essen
Country [24] 0 0
Germany
State/province [24] 0 0
Gera
Country [25] 0 0
Germany
State/province [25] 0 0
Goettingen
Country [26] 0 0
Germany
State/province [26] 0 0
Heidelberg
Country [27] 0 0
Germany
State/province [27] 0 0
Kiel
Country [28] 0 0
Germany
State/province [28] 0 0
Koeln
Country [29] 0 0
Germany
State/province [29] 0 0
Magdeburg
Country [30] 0 0
Germany
State/province [30] 0 0
Mainz
Country [31] 0 0
Germany
State/province [31] 0 0
Nuernberg
Country [32] 0 0
Germany
State/province [32] 0 0
Recklinghausen
Country [33] 0 0
Germany
State/province [33] 0 0
Tubingen
Country [34] 0 0
Greece
State/province [34] 0 0
Athens
Country [35] 0 0
Greece
State/province [35] 0 0
Neo Faliro
Country [36] 0 0
Israel
State/province [36] 0 0
Haifa
Country [37] 0 0
Israel
State/province [37] 0 0
Jerusalem
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Hashomer
Country [39] 0 0
Italy
State/province [39] 0 0
Bari
Country [40] 0 0
Italy
State/province [40] 0 0
Bergamo
Country [41] 0 0
Italy
State/province [41] 0 0
Genova
Country [42] 0 0
Italy
State/province [42] 0 0
Meldola (fc)
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Napoli
Country [45] 0 0
Italy
State/province [45] 0 0
Padova
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Italy
State/province [47] 0 0
Siena
Country [48] 0 0
Mexico
State/province [48] 0 0
Distrito Federal
Country [49] 0 0
Mexico
State/province [49] 0 0
Guanajuato
Country [50] 0 0
Mexico
State/province [50] 0 0
Michoacan
Country [51] 0 0
Norway
State/province [51] 0 0
Oslo
Country [52] 0 0
Poland
State/province [52] 0 0
Gdansk
Country [53] 0 0
Poland
State/province [53] 0 0
Lodz
Country [54] 0 0
Poland
State/province [54] 0 0
Warszawa
Country [55] 0 0
Spain
State/province [55] 0 0
Guipuzcoa
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Sweden
State/province [60] 0 0
Gothenberg
Country [61] 0 0
Sweden
State/province [61] 0 0
Lund
Country [62] 0 0
Sweden
State/province [62] 0 0
Umea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT01721772
Trial related presentations / publications
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. Erratum In: JAMA Oncol. 2019 Feb 1;5(2):271. doi: 10.1001/jamaoncol.2018.6113.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01721772