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-

Trial Details

NCT ID
NCT07349303
Phase
PHASE2
Sponsor
Vastra Gotaland Region
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Pembrolizumab
  • Placebo
Locations (sample)
  • Gothenburg, Sweden|57.70716,11.96679

Key Eligibility Criteria

  • Patient is ≥18 years.
  • Signed informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Histopathologically confirmed primary cutaneous melanoma stage IIb/c (Breslow \>2.0 mm with ulceration OR Breslow \>4.0mm without ulceration) with …

For full eligibility, visit ClinicalTrials.gov.

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