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Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma
Sponsor: Vastra Gotaland Region
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.
Official title: Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma, a Phase II Double-blind Placebo-controlled Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-01-15
Completion Date
2031-05-15
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Immunotherapy
Placebo
Placebo
Locations (1)
Sahlgrenska University Hospital
Gothenburg, Sweden