drugset / Trial / NCT05647954
A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS) and Overall Survival(OS), achieved by HX008 Plus Transcatheter Arterial Chemoembolization (TACE) or Temozolomide Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver.
Timeline
- Start
- 2022-12-31
- Primary completion
- 2024-12-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pembrolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Pucotenlimab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | Temozolomide | Small molecule | 200 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | fotemustine | Small molecule | 100 mg/m2 | — |
| Background | lipiodol | Unknown | 5 ml | — |
| Background | lipiodol | Unknown | 10 ml | — |