Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

Recruiting Phase 2 Interventional Study
Melanoma (Skin Cancer)
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Vastra Gotaland Region · Government
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About This Trial
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 ly…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient is ≥18 years. 2. Signed informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4. Histopathologically confirmed primary cutaneous melanoma stage IIb/c (Breslow \>2.0 mm with ulceration OR Breslow \>4.0mm without ulceration) with a min…
Contacts

Roger Olofsson Bagge, Professor

+46 31 3421000

roger.olofsson.bagge@vgregion.se

CONTACT

Axel Nelson, MD, PhD

axel.nelson@vgregion.se

CONTACT