Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

A phase II double-blind placebo-controlled randomized trial. Patients with a clinical suspicion of a thick primary melanoma without clinical suspicion or evidence of lymph-node engagement will undergo a 3 mm punch biopsy to verify the diagnosis and ascertain eligibility. Patients will receive 1 cycle of pembrolizumab 400 mg or placebo and 4 weeks later undergo a wide local excision and sentinel lymph node biopsy according to the national guideline recommendations . The primary objective is to evaluate the pathological response of one cycle of neoadjuvant pembrolizumab in patients with biopsy-proven stage IIb/c melanoma. Secondary objectives include efficacy and safety analysis, as well as biomarker discovery.

NCT Number	NCT07349303
Lead Sponsor	Vastra Gotaland Region
Conditions	Melanoma (Skin Cancer)
Enrollment	30 participants
Start Date	2026-01-15
Primary Completion	2029-05-15 (estimated)
Study Completion	2031-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-21