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RECRUITING
NCT07349303
PHASE2

Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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

Interventions

DRUG

Pembrolizumab

Immunotherapy

DRUG

Placebo

Placebo

Locations (1)

Sahlgrenska University Hospital

Gothenburg, Sweden