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Unresectable or Metastatic MelanomaPhase 3NCT01721746

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

A Phase 3 study testing BMS-936558, Dacarbazine and Carboplatin in people with Unresectable or Metastatic Melanoma, run by Bristol-Myers Squibb at 95 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable or Metastatic Melanoma
What is being tested?
BMS-936558, Dacarbazine and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
95 sitesin 14 countries
Study dates
21 Dec 2012to 29 Dec 2020
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 \& women ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Histologically confirmed Stage III (unresectable)/Stage IV melanoma
  • Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
  • Pre-treatment fresh core, excision or punch tumor biopsy
  • Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

Who cannot join

  • Any treatment in a BMS-936558 (Nivolumab) trial
  • Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
  • Active, known or suspected autoimmune disease
  • Unknown BRAF status
  • Active brain metastasis or leptomeningeal metastasis
  • Ocular melanoma
  • Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)

Trial locations and contacts

95 sites in 14 countries.

95 sites in 14 countries

United States32 sites

  • Network Office of Research and Innovation

    Allentown, Pennsylvania, 18103

  • St. Luke'S Health System

    Allentown, Pennsylvania, 18109

  • University Of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University Of Colorado

    Aurora, Colorado, 80045

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University Hospitals

    Cleveland, Ohio, 44106

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • The Angeles Clinic & Research Institute

    Los Angeles, California, 90025

  • University Of California - Los Angeles

    Los Angeles, California, 90095

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Allina Health

    Minneapolis, Minnesota, 55407

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • MSKCC Clinical Laboratory at Nassau

    New York, New York, 10065

  • Orlando Health, Inc

    Orlando, Florida, 32806

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Oncology And Hematology

    Portland, Oregon, 97213

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • San Francisco Oncology Associates

    San Francciso, California, 94115

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

Germany12 sites

  • Local Institution

    Buxtehude, 21614

  • Local Institution

    Dresden, 01307

  • Local Institution

    Essen, 45122

  • Local Institution

    Frankfurt am Main, 60590

  • Local Institution

    Hanover, 30625

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Kiel, D-24105

  • Local Institution

    Lübeck, 23538

  • Local Institution

    Magdeburg, 39120

  • Local Institution

    Munich, 81675

  • Local Institution

    Tübingen, 72076

  • Local Institution

    Würzburg, Bavaria, 97080

Other trials in Germany

Italy9 sites

  • Local Institution

    Bari, 70124

  • Local Institution

    Bergamo, 24127

  • Local Institution

    Genova, 16132

  • Local Institution

    Milan, 20133

  • Local Institution

    Milan, 20141

  • Local Institution

    Naples, 80131

  • Local Institution

    Padova, 35128

  • Local Institution

    Roma, 00144

  • Local Institution

    Siena, 53100

Other trials in Italy

France8 sites

  • Local Institution

    Clermont-Ferrand, 63003

  • Local Institution

    Lille, 59037

  • Hopital La Timone

    Marseille, 13009

  • Local Institution

    Nantes, 44093

  • Local Institution

    Nice, 06200

  • Local Institution

    Paris, 75010

  • Local Institution

    Pierre-Bénite, 69310

  • Local Institution

    Villejuif, 94805

Other trials in France

Spain6 sites

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Barcelona, 08908

  • Local Institution

    Madrid, 28020

  • Local Institution

    Madrid, 28041

  • Local Institution

    Pamplona, 31192

  • Local Institution

    Valencia, 46014

Other trials in Spain

United Kingdom5 sites

  • Local Institution

    London, SW3 6JJ

  • Local Institution

    Manchester, Greater Manchester, M20 4BX

  • Local Institution

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Local Institution

    Oxford, Oxfordshire, OX3 7LJ

  • Local Institution

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Belgium4 sites

  • Local Institution

    Brussels, 1090

  • Local Institution

    Brussels, 1200

  • Local Institution

    Edegem, 2650

  • Local Institution

    Leuven, 3000

Other trials in Belgium

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUM

    Montreal, Quebec, H2X 3E4

  • Sir Mortimer B Davis - Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Brazil3 sites

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution

    Rio de Janeiro, 20220-410

  • Local Institution

    São Paulo, 01321-001

Other trials in Brazil

Denmark3 sites

  • Aarhus Universitetshospital

    Aarhus, 8000

  • Herlev Hospital

    Herlev, 2730

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Netherlands3 sites

  • Local Institution

    Amsterdam, 1066 CX

  • Local Institution

    Groningen, 9713 GZ

  • Local Institution

    Maastricht, 6229 HX

Other trials in Netherlands

Austria2 sites

  • Local Institution

    Innsbruck, 6020

  • Local Institution

    Vienna, A-1090

Other trials in Austria

Israel2 sites

  • Local Institution

    Jerusalem, 91120

  • Local Institution

    Ramat Gan, 52621

Other trials in Israel

Switzerland2 sites

  • Local Institution

    Lausanne, 1011

  • Local Institution

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

Being tested
BMS-936558, Dacarbazine, Carboplatin, Paclitaxel
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-936558Biological

  • DacarbazineDrug

    Also called DTIC-Dome, DTIC

  • CarboplatinDrug

    Also called Paraplatin, CBDCA

  • PaclitaxelDrug

    Also called Onxol

Study groups in NCT01721746
Study groupRoleWhat they receive
BMS-936558 3 mg/kg (IV)ExperimentalBMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Receives: Biological: BMS-936558
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)Active comparatorDacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Receives: Drug: Dacarbazine; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1

    Measured: From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)

  2. Overall Survival (OS)

    Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.

    Measured: Up to 96 months

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.

    Measured: From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)

  2. Objective Response Rate (ORR) by Baseline PD-L1 Expression

    Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.

    Measured: From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)

  3. Overall Survival (OS) by PD-L1 Positive

    Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Measured: Up to 96 months

  4. Overall Survival (OS) by PD-L1 Negative

    Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

    Measured: Up to 96 months

  5. Mean Change From Baseline in Health-related Quality of Life (HRQoL)

    Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.

    Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.

    A 10 point difference on a 100 point scale between treatments was considered clinically significant.

    Measured: From Baseline (Day1) to second Follow-Up (Up to 96 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2012 (estimated)
  2. Study start21 Dec 2012
  3. Primary completion16 Feb 2016
  4. Study completion29 Dec 2020

Resources

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
None (open label)
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01721746
Sponsor's protocol ID
CA209-037
Other IDs
2012-001828-35
Status last verified
Mar 2022
First submitted
2 Nov 2012
Last updated
19 Apr 2022
Data monitoring committee
Yes

Publications

  • Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J Clin Oncol. 2018 Feb 1;36(4):383-390. doi: 10.1200/JCO.2016.71.8023. Epub 2017 Jul 3.

    PubMed 28671856

  • Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, Hoeller C, Khushalani NI, Miller WH Jr, Lao CD, Linette GP, Thomas L, Lorigan P, Grossmann KF, Hassel JC, Maio M, Sznol M, Ascierto PA, Mohr P, Chmielowski B, Bryce A, Svane IM, Grob JJ, Krackhardt AM, Horak C, Lambert A, Yang AS, Larkin J. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375-84. doi: 10.1016/S1470-2045(15)70076-8. Epub 2015 Mar 18.

    PubMed 25795410

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BMS-936558, Dacarbazine and Carboplatin in people with Unresectable or Metastatic Melanoma, run by Bristol-Myers Squibb at 95 sites in 14 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 7 inclusion and 7 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Germany, Italy, France, Spain and 9 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 22 Mar 2017). 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?

Objective Response Rate (ORR) (time frame: From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 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 NCT01721746, which also lists 2 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 19 Apr 2022.

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