This study is being performed to evaluate the safety and efficacy of Dacarbazine and OrienX010 therapy in Untreated Patients With Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Melanoma. The study will be conducted in about 6 centres in China and total 165 patients will be enrolled. All eligible Patients will be randomized between Dacarbazine and OrienX010 in a 1:2 ratio, so 1/3 (55) patients will receive the Dacarbazine and 2/3 (110) patients will receive the OrienX010. During the treatment phase, the patient will receive OrienX010 administration once biweekly or Dacarbazine once every 3 week until to the end of treatment (EOT). The duration of safety follow-up for adverse events (AEs) and serious adverse events (SAEs) will be to 90 days after the end of treatment. The details please refer to study schema. For patients who have completed the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event. After the end of study, if patient want to continue receiving the OrienX010 treatment and judged by investigator, sponsor will provide OrienX010 and Dacarbazine for free until disease progression/death or OrienX010 on marketing launch.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
OrienX010 to be used in this study have been developed and manufactured by OrienGene Biotechnology Ltd. Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPFS
Progression-free survival (PFS), defined as the first documentation of objective disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1)
Time frame: Every 12 weeks until subjects disease progressive, an average of 24 weeks
DCR
Disease Control Rate (DCR), defined as the proportion of subjects with complete response, partial response, or stable disease for more than 3 months, according to RECIST v.1.1 criteria
Time frame: through study completion, an average of 1 year
ORR
Objective Response Rate (ORR), defined as complete or partial tumor response, according to RECIST v.1.1 criteria
Time frame: through study completion, an average of 1 year
OS
Overall survival defined as the time from randomization to death from any cause
Time frame: Approximately 3 years
DRR
Durable response rate (DRR) defined as objective response lasting continuously ≥ 6 months
Time frame: through study completion, an average of 1 year
Quality of life assessment
Use EORTC QLQ-C30 to assess quality of life. The EORTC(European Organization for Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire C30), is a cancer-specific quality of life instrument applicable to a broad range of cancer patients. QLQ-C30 contain 15 domain, The standard score for each domain from 0-100. higher scores mean a worse outcome.
Time frame: every 6 weeks up to 24 weeks, and then every 12 weeks up to the date of end of treatment,an average of 24 weeks
Incidence of treatment-related SAE and AE
Number of participants with treatment-related serious adverse events (SAE) and adverse events that assessed by CTCAE v4.03
Time frame: From date of enrolling to 90 days after end of treatment
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