NCT04331093

Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma

A Single-cencer,Phase II Study of Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Di Wu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Acral melanoma is a melanoma that affects acral areas of the skin, which is the most prevalent site of melanoma in non-Caucasians.Data in this subgroup is scarce.This study is to evalueate the efficiency and safety of Neoadjuvant SHR-1210 plus apatinib in this particular group,menawhile to determine the predictive value for efficiency of several biomarkers.

Detailed description

SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).

Conditions

• Acral Melanoma

Interventions

Type	Name	Description
DRUG	SHR-1210+Apatinib	Drug: SHR-1210 SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg Drug: Apatinib Apatinib tablet will be administered orally,once daily until progression

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2020-04-02
• Last updated: 2021-05-26

Locations

1 site across 1 country: China