NCT05087602

Toripalimab Combined With Anlotinib in Unresectable Locally Advanced or Metastatic Acral Malignant Melanoma

Study of PD-1 Toripalimab Combined With Anlotinib in Unresectable Locally Advanced or Metastatic Acral Malignant Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate PFS of PD-1 Toripalimab Combined With Anlotinib in Subjects With unresectable locally advanced or metastatic acral malignant melanoma

Detailed description

Malignant melanoma (MM) is one of the most malignant tumors. It is easy to metastasize at an early stage, has a high mortality rate, and its incidence is increasing year by year. This study aims to evaluate the effectiveness and safety of the combined application of Anlotinib Hydrochloride Capsules and Toripalimab in the treatment of unresectable stage III and stage IV acral malignant melanoma confirmed by pathology.

Conditions

• Locally Advanced or Metastatic Acral Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Toripalimab and Anlotinib	Toripalimab 240 mg IV on Day 1 of each 14-day cycle plus Anlotinib capsules given 10mg orally in fasting conditions , once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-09-30
• Completion: 2023-10-30
• First posted: 2021-10-21
• Last updated: 2021-10-21

Locations

1 site across 1 country: China