Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma
Sponsor: Vastra Gotaland Region • ClinicalTrials.gov ID: NCT07349303
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
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.
Interventions
-
Pembrolizumab
(Drug)
Immunotherapy
-
Placebo
(Drug)
Placebo
Eligibility criteria
Conditions
Locations
- Sahlgrenska University Hospital — Gothenburg, Sweden
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record