To evaluate the feasibility, safety, and preliminary efficacy of combining topical imiquimod with intravenous pembrolizumab in patients with unresectable melanoma with cutaneous metastases, focusing on the primary endpoint of objective response rate.
Key Findings:
Seven patients were enrolled; 5 male and 2 female.
Objective response rate (ORR) was 57.1%, with 3 patients achieving complete response (CR), 1 partial response, and 2 stable disease.
The 7-month progression-free survival (PFS) rate was 57.1%.
Toxicities were mostly grade 1, with fatigue and anemia being the most common.
Interpretation:
The combination of topical imiquimod and pembrolizumab was feasible, safe, and demonstrated promising antitumor activity in unresectable cutaneous melanoma, suggesting potential for future research.
Limitations:
Small sample size of seven patients.
Non-randomized design limits generalizability.
Lack of control group affects the strength of conclusions.
Conclusion:
A 42.9% complete response rate in this small cohort supports further evaluation of local immune modulation with systemic PD-1 blockade for cutaneous melanoma, highlighting the need for larger studies.
