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A Randomized, Controlled, Multi-center, Phase III Clinical Study to Investigate Recombinant Humanized PD-1 Monoclonal Antibody Injection (JS001) Versus Dacarbazine as the 1st-line Therapy for Unresectable or Metastatic Melanoma

Trial Profile

A Randomized, Controlled, Multi-center, Phase III Clinical Study to Investigate Recombinant Humanized PD-1 Monoclonal Antibody Injection (JS001) Versus Dacarbazine as the 1st-line Therapy for Unresectable or Metastatic Melanoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Toripalimab (Primary) ; Dacarbazine
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms MELATORCH
  • Sponsors Shanghai Junshi Biosciences

Most Recent Events

  • 28 Apr 2025 According to a Junshi Biosciences media release, based on results from this trial, the supplemental new drug application ("NDA") for toripalimab (trade name: TUOYI) as the first-line treatment for unresectable or metastatic melanoma has been approved by the National Medical Products Administration ("NMPA").
  • 25 Apr 2025 According to a Junshi Biosciences media release, the results from this study were first presented at the 27th National Clinical Oncology Conference and the 2024 Annual Meeting of the Chinese Society of Clinical Oncology (CSCO).
  • 06 Jan 2025 According to a Junshi Biosciences media release, based on data from this trial, company announces routine approval of toripalimab for second-line and above melanoma treatment. This routine approval means that toripalimab has completed the necessary confirmatory clinical trials as required by regulatory authorities and proved its effectiveness and safety in the target population.

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