A Phase ? Study to Investigate Toripalimab Versus Dacarbazine as the First Line Therapy for Unresectable or Metastatic Melanoma

Summary

Participation Requirements

Description

In the subjects who have clinical benefit evaluated by investigators and tolerate the study treatment, treatment will be considered to give after occurrence of progression defined by RECIST1.1 as evaluated by the initial investigators, these subjects must terminate the treatment when further progres...

In the subjects who have clinical benefit evaluated by investigators and tolerate the study treatment, treatment will be considered to give after occurrence of progression defined by RECIST1.1 as evaluated by the initial investigators, these subjects must terminate the treatment when further progression is validated. The subjects in dacarbazine treatment group are allowed to be crossed to receive JS001 after progression of disease; however, they need to be re-evaluated if they meet the inclusion/exclusion criteria. Subjects need to provide one tumor tissue specimen for archival or one newly acquired biopsy tissue from the site that is previously not irradiated for evaluation of PD-L1 expression status when they participate in the study. The PD-L1 expression status of specimen will be evaluated in the central laboratory using immunohistochemical (IHC) method. Subjects with positive or negative PD-L1 can be enrolled in this study, and the clinical activity in the two subgroups will be evaluated in accordance with the prespecified subgroup analysis.

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