MelanomaPhase 3CheckMate 066NCT01721772
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
A Phase 3 study testing BMS-936558 (Nivolumab) and Dacarbazine in people with Melanoma, run by Bristol-Myers Squibb at 75 sites in 16 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- BMS-936558 (Nivolumab) and Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 418 participants
- Where
- 75 sitesin 16 countries
- Study dates
- 18 Jan 2013to 14 May 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Any active, known, or suspected autoimmune disease
Trial locations and contacts
75 sites in 16 countries.
75 sites in 16 countries
Germany12 sites
Local Institution
Cologne, 50937
Local Institution
Essen, 45122
Local Institution
Gera, 07548
Local Institution
Göttingen, 37075
Local Institution
Heidelberg, 69120
Local Institution
Kiel, 24105
Local Institution
Magdeburg, 39120
Local Institution
Mainz, 55131
Local Institution
Nuremberg, 90419
Local Institution
Recklinghausen, 45659
Local Institution
Tübingen, 72076
Local Institution
Würzburg, Bavaria, 97080
Italy10 sites
Local Institution
Bari, 70124
Local Institution
Bergamo, 24127
Local Institution
Genova, 16132
Local Institution
Meldola (fc), 47014
Local Institution
Milan, 20133
Local Institution
Milan, 20141
Local Institution
Naples, 80131
Local Institution
Padova, 35128
Local Institution
Roma, 00144
Local Institution
Siena, 53100
Australia9 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Local Institution
Camperdown, New South Wales, 2050
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Cabrini Hospital
Malvern, Victoria, 3144
Local Institution - 0006
North Sydney, New South Wales, 2060
Local Institution
Southport, Queensland, 4215
Local Institution
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Canada6 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Qe Ii Health Science Centre
Halfax, Nova Scotia, B3H 2Y9
Local Institution - 0040
Montreal, Quebec, H4A 3J1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Local Institution - 0039
Vancouver, British Columbia, V5Z 4E6
France6 sites
Hopital Saint Andre
Bordeaux, 33075
Chu Grenoble - Hopital Albert Michallon
Grenoble, 38043
Chru De Lille - Hopital Claude Huriez
Lille, 59037
Hopital St Eloi
Montpellier, 34295
Hopital Saint Louis
Paris, 75010
Local Institution - 0013
Villejuif, 94805
Spain6 sites
Local Institution - 0056
Barcelona, 08036
Local Institution
Donostia / San Sebastian, Guipuzcoa, 20014
Local Institution
Madrid, 28033
Local Institution
Madrid, 28034
Local Institution
Seville, 41009
Local Institution
Valencia, 46014
Mexico4 sites
Local Institution
Leon, Guanajato, Guanajuato, 37000
Local Institution
Mexico City, Mexico City, 03310
Local Institution
Morelia, Michoacán, 58240
Local Institution
Tlalpan, Mexico City, 14080
Argentina3 sites
Fundacion Cidea
Buenos Aires, Distrito Federal, 1121
Instituto Medico Especialazado Alexander Fleming
Buenos Aires, C1426ANZ
Instituto Oncologico De Cordoba
Córdoba, 5000
Chile3 sites
Local Institution
Santiago, Santiago Metropolitan
Local Institution
Santiago, 7630370
Local Institution
Viña del Mar, Valparaiso
Denmark3 sites
Aarhus Universitetshospital
Aarhus, 8000
Herlev Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
Israel3 sites
Local Institution
Haifa, 34362
Local Institution
Jerusalem, 91120
Local Institution
Tel HaShomer, 52621
Poland3 sites
Local Institution
Gdansk, 80-219
Local Institution
Lodz, 93-513
Local Institution
Warsaw, 02-781
Sweden3 sites
Local Institution
Gothenberg, 413 45
Local Institution
Lund, 221 85
Local Institution
Umeå, 901 85
Greece2 sites
Laiko Hospital
Athens, 11527
Metropolitan Hospital
Neo Faliro, 18547
About this study
Official title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
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
- Conditions
- Melanoma
- Being tested
- BMS-936558 (Nivolumab), Placebo matching BMS-936558 (Nivolumab), Dacarbazine, Placebo matching Dacarbazine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-936558 (Nivolumab)Biological
Placebo matching BMS-936558 (Nivolumab)Biological
DacarbazineDrug
Placebo matching DacarbazineDrug
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab, 3 mg/kg | Experimental | 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. Receives: Biological: BMS-936558 (Nivolumab); Drug: Placebo matching Dacarbazine |
| Dacarbazine, 1000 mg/m^2 | Active comparator | 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. Receives: Biological: Placebo matching BMS-936558 (Nivolumab); Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
Measured: 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.
Overall Survival (OS) Rate
OS rate is calculated as the percentage of participants alive at the indicated timepoints
Measured: From randomization to 6 months and or to 12 months
Secondary outcomes (5)
Progression-free Survival (PFS)
Investigator-assessed 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. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.
Measured: From date of randomization up to date of disease progression or death, up to approximately 84 months
Progression-free Survival (PFS) Rate
The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.
Measured: From randomization to the specified timepoints, up to 84 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.
Measured: 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
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression <5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.
Measured: From date of randomization to date of disease progression or death, up to approximately 94 months
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
Measured: At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study start18 Jan 2013
- Primary completion24 Jun 2014
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721772
- Sponsor's protocol ID
- CA209-066
- Other IDs
- 2012-003718-16
- Acronym
- CheckMate 066
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2012
- Last updated
- 12 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39504507Robert 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.
PubMed 32997575Ascierto 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.
PubMed 30422243Long 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.
PubMed 30215677Long 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.
PubMed 28662232Robert 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.
PubMed 25399552
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01721772
- Acronym / sponsor ID
- CheckMate 066 / CA209-066
- Conditions
- Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2013 (actual)
- Primary completion
- 24 Jun 2014 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Posted 25 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab, 3 mg/kg | Experimental | Biological: BMS-936558 (Nivolumab), Drug: Placebo matching DacarbazineParticipants 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. |
| Dacarbazine, 1000 mg/m^2 | Active comparator | Biological: Placebo matching BMS-936558 (Nivolumab), Drug: DacarbazineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Any active, known, or suspected autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-936558 (Nivolumab) | Biological | Nivolumab, 3 mg/kg |
| Placebo matching BMS-936558 (Nivolumab) | Biological | Dacarbazine, 1000 mg/m^2 |
| Dacarbazine | Drug | Dacarbazine, 1000 mg/m^2 |
| Placebo matching Dacarbazine | Drug | Nivolumab, 3 mg/kg |
Primary outcome
Overall Survival (OS)
Time frame: 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.
OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
Overall Survival (OS) Rate
Time frame: From randomization to 6 months and or to 12 months
OS rate is calculated as the percentage of participants alive at the indicated timepoints
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: From date of randomization up to date of disease progression or death, up to approximately 84 months
Progression-free Survival (PFS) Rate
Time frame: From randomization to the specified timepoints, up to 84 months
Objective Response Rate (ORR)
Time frame: 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
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
Time frame: From date of randomization to date of disease progression or death, up to approximately 94 months
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Time frame: At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39504507Long 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.
- Derived from this study: PubMed 32997575Robert 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.
- Derived from this study: PubMed 30422243Ascierto 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.
- Derived from this study: PubMed 30215677Long 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.
- Derived from this study: PubMed 28662232Long 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.
- Derived from this study: PubMed 25399552Robert 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
75 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BMS-936558 (Nivolumab) and Dacarbazine in people with Melanoma, run by Bristol-Myers Squibb at 75 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Germany, Italy, Australia, Canada, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721772, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.