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.
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…
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