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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01721746
First received: November 2, 2012
Last updated: February 1, 2017
Last verified: February 2017

November 2, 2012
February 1, 2017
December 2012
February 2016   (Final data collection date for 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; approx. 16 months ]
    ORR was 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. BOR was defined as the best response designation, as determined by the independent review committee (IRC), recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Analysis made at Primary Endpoint; Study On-going.
  • Median Overall Survival (OS) at Primary Endpoint [ Time Frame: From the date of randomization to the date of death; up to 37 months ]
    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. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. This interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going.
  • Objective response rate (ORR) of BMS-936558 in subjects with advanced melanoma [ Time Frame: 23 months ]
    ORR is defined as the number of subjects with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized subjects
  • Overall survival(OS) of BMS-936558 in subjects with advanced melanoma [ Time Frame: 23 months ]
    Overall Survival (OS) is defined the time between the date of randomization to the date of death
Complete list of historical versions of study NCT01721746 on ClinicalTrials.gov Archive Site
  • Median Months of Progression-free Survival (PFS) Per IRRC [ Time Frame: From the date of randomization to the date of the first documented progression or death; up to 37 months ]
    PFS was defined as the time from randomization to the date of the first documented progression, as determined by the IRC, 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. Participants who did not have any on study tumor assessments and did not die were censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery) without a prior reported progression were censored at the last evaluable tumor assessment prior to or upon initiation of the subsequent anti-cancer therapy. An Independent Radiology Review Committee (IRC/IRRC) reviewed all available tumor assessment scans to determine response (RECIST 1.1). Analysis made at Primary Endpoint; Study On-going.
  • 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; approx. 16 months ]
    PD-L1 expression evaluated as a predictive biomarker for ORR by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as "Subjects without Tumor Tissue Samples". ORR=number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. Analysis made at Primary Endpoint; Study On-going.
  • Median Overall Survival (OS) Time in Months by Baseline PD-L1 Expression [ Time Frame: From the date of randomization to the date of death; up to 37 months ]
    PD-L1 expression evaluated as a predictive biomarker for OS by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as "Subjects without Tumor Tissue Samples". 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. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. The interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going.
  • Mean Change From Baseline in Health-related Quality of Life (HRQoL) Global Health Status Scores [ Time Frame: From Baseline (Day1) to second Follow-Up; up to 37 months ]
    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; an increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL; a 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.
  • Progression-free survival (PFS) [ Time Frame: 23 months ]
    PFS is defined as the time from randomization to the date of the first documented progression or death due to any cause, whichever occurs first
  • Programmed death-ligand 1 (PD-L1) expression [ Time Frame: 23 months ]
    To evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS by testing the interaction between PD-L1 expression and treatment arms
  • Health Related Quality of Life (HRQoL) [ Time Frame: Baseline (Day1) and 23 months ]
    HRQoL will be measured by mean changes from screening/baseline in the EORTC QLQ-C30 global health status/QoL composite scale and by mean changes from screening/baseline in the remaining EORTC QLQ-C30 scales in all randomized subjects
Not Provided
Not Provided
 
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 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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Unresectable or Metastatic Melanoma
  • Biological: BMS-936558
  • Drug: Dacarbazine
    Other Names:
    • DTIC-Dome
    • DTIC
  • Drug: Carboplatin
    Other Names:
    • Paraplatin
    • CBDCA
  • Drug: Paclitaxel
    Other Name: Onxol
  • Experimental: BMS-936558 3 mg/kg (IV)
    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: Biological: BMS-936558
  • Active Comparator: Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

    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

    Interventions:
    • Drug: Dacarbazine
    • Drug: Carboplatin
    • Drug: Paclitaxel
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
631
September 2018
February 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   France,   Germany,   Israel,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom
 
 
NCT01721746
CA209-037
2012-001828-35 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP