Trials / Unknown

UnknownNCT05647954

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

A Randomized, Open-Label, Multicenter, Phase III Study of HX008 (a Humanized Monoclonal Antibody Against PD-1) Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver

Status: Unknown
Phase: Phase 3
Study type: Interventional
Enrollment: 350 (estimated)

Sponsor: Taizhou Hanzhong biomedical co. LTD · Industry
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

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.

Conditions

Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms

Interventions

Type	Name	Description
DRUG	HX008 + TACE	HX008 Subjects receive HX008 200 mg intravenous (IV) ,day1,every 3 weeks (Q3W) Procedure: TACE cisplatin 75 mg/sqm, day1, every 6 weeks; fotemustine 100 mg/sqm, day2, every 6 weeks; lipiodol is usually 5-10 ml (According to the location and number of lesions).
DRUG	Temozolomide + TACE	Temozolomide Subjects receive Temozolomide 200 mg/sqm intravenous (IV),day1-5, every 3 weeks (Q3W) Procedure: TACE : cisplatin 75 mg/sqm, day1, every 6 weeks; fotemustine 100 mg/sqm, day2, every 6 weeks; lipiodol is usually 5-10 ml (According to the location and number of lesions).
DRUG	Pembrolizumab	Subjects receive Pembrolizumab 2 mg/kg intravenous (IV),day1, every 3 weeks (Q3W)

Timeline

Start date: 2022-12-31
Primary completion: 2024-12-30
Completion: 2025-06-30
First posted: 2022-12-13
Last updated: 2022-12-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05647954. Inclusion in this directory is not an endorsement.