Apatinib combined with camrelizumab in advanced acral melanoma patients: An open-label, single-arm phase 2 trial

Area of Science:

• Oncology
• Immunotherapy
• Clinical Trials

Background:

• Acral melanoma, particularly advanced stages, lacks satisfactory treatment options with current immune monotherapy and combination therapies.
• No established standard treatment exists for advanced acral melanoma, highlighting the need for novel therapeutic strategies.

Purpose of the Study:

• To evaluate the safety and efficacy of apatinib in combination with camrelizumab as a first-line treatment for patients with advanced acral melanoma.
• To assess the objective response rate, disease control rate, survival outcomes, and toxicity profile of this combination therapy.

Main Methods:

• A phase II clinical trial (NCT03955354) was conducted involving patients with pathologically confirmed, locally unresectable or metastatic acral melanoma.
• Participants received daily apatinib (250 mg) and bi-weekly camrelizumab (200 mg) intravenously over 28-day cycles.
• Primary endpoint was objective response rate; secondary endpoints included disease control rate, overall survival, progression-free survival, and safety assessments.

Main Results:

• The study enrolled 30 patients, with 70% having stage IV disease and a median tumor burden of 50 mm.
• An objective response rate of 24.1% was observed, with 7 patients achieving partial or complete responses.
• The disease control rate was 82.8%, with a median progression-free survival of 7.39 months and median overall survival of 13.4 months.
• Grade 3-4 toxicities included elevated transaminases, proteinuria, and leukocytopenia, but no treatment-related mortality occurred.
• Specific gene mutations (TTN, MUC16, VPS13D, ALPK2, SCUBE1) were significantly associated with survival outcomes.

Conclusions:

• The combination of apatinib and camrelizumab demonstrates a manageable safety profile in advanced acral melanoma patients.
• This combination therapy exhibits reasonable anti-tumor activity, suggesting its potential as a first-line treatment option for this patient population.