NCT07349303

Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma, a Phase II Double-blind Placebo-controlled Randomized Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma (Skin Cancer)

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Immunotherapy
DRUG	Placebo	Placebo

Timeline

• Start date: 2026-01-15
• Primary completion: 2029-05-15
• Completion: 2031-05-15
• First posted: 2026-01-16
• Last updated: 2026-01-21

Locations

1 site across 1 country: Sweden