Overview

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

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

This is one phase Ⅲ, randomized, open-label study in comparison of JS001 with dacarbazine as the 1st-line therapy for adult (≥18 years) subjects with unresectable or metastatic melanoma. The subjects will be 1:1 randomized and stratified in accordance with acral lentiginous melanoma and M stage (M0vsM1a/M1bvsM1c). Using standard dose and dose interval, the subjects will be given JS001 240mg intravenously, once every two weeks, or dacarbazine 1000mg/m2, d1, intravenously, once every three weeks. One cycle of therapy is 6 weeks (3 doses of JS001 or 2 doses of dacarbazine per cycle).

Phase:

Phase 3

Details

Lead Sponsor:

Shanghai Junshi Bioscience Co., Ltd.
Shanghai Junshi Bioscience Co.,Ltd.

Treatments:

Antibodies
Antibodies, Monoclonal
Dacarbazine