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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
405
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
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)
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.
Time frame: Up to 96 months
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.
Time frame: From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
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.
Time frame: From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
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Mayo Clinic
Phoenix, Arizona, United States
UCSD Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic & Research Institute
Los Angeles, California, United States
University Of California - Los Angeles
Los Angeles, California, United States
San Francisco Oncology Associates
San Francciso, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
University Of Colorado
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Orlando Health, Inc
Orlando, Florida, United States
...and 85 more locations
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.
Time frame: Up to 96 months
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.
Time frame: Up to 96 months
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.
Time frame: From Baseline (Day1) to second Follow-Up (Up to 96 months)