TriangleNCT01721746 · CITED IN SOURCE DOCUMENTS
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)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2022-04-19
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
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
Objective Response Rate (ORR) by Baseline PD-L1 Expression
Overall Survival (OS) by PD-L1 Positive
Overall Survival (OS) by PD-L1 Negative
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * 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 Exclusion Criteria: * 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)
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- BMS-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
- intervention Names
- Biological: BMS-936558
- label
- BMS-936558 3 mg/kg (IV)
- type
- EXPERIMENTAL
- description
- Dacarbazine: 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
- intervention Names
- Drug: Dacarbazine
- Drug: Carboplatin
- Drug: Paclitaxel
- label
- Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- BMS-936558 3 mg/kg (IV)
- name
- BMS-936558
- type
- BIOLOGICAL
- arm Group Labels
- Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
- name
- Dacarbazine
- other Names
- DTIC-Dome
- DTIC
- type
- DRUG
- arm Group Labels
- Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
- name
- Carboplatin
- other Names
- Paraplatin
- CBDCA
- type
- DRUG
- arm Group Labels
- Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
- name
- Paclitaxel
- other Names
- Onxol
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 405
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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
- 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)
- description
- 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.
- measure
- Overall Survival (OS)
- time Frame
- Up to 96 months
- secondary Outcomes
- description
- 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.
- measure
- Progression Free Survival (PFS)
- time Frame
- From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
- description
- 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.
- measure
- Objective Response Rate (ORR) by Baseline PD-L1 Expression
- time Frame
- From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
- description
- 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.
- measure
- Overall Survival (OS) by PD-L1 Positive
- time Frame
- Up to 96 months
- description
- 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.
- measure
- Overall Survival (OS) by PD-L1 Negative
- time Frame
- Up to 96 months
- description
- 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.
- measure
- Mean Change From Baseline in Health-related Quality of Life (HRQoL)
- time Frame
- From Baseline (Day1) to second Follow-Up (Up to 96 months)
Full study description
- brief 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
Source references
- references
- citation
- 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.
- pmid
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- type
- DERIVED
- citation
- 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.
- pmid
- 25795410
- type
- DERIVED
- see Also Links
- label
- BMS Clinical Trial Information
- label
- BMS Clinical Trial Patient Recruiting
- label
- Investigator Inquiry Form
- label
- FDA Safety Alerts and Recalls
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice