Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma, a Phase II Double-blind Placebo-controlled Randomized 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 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.
• 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 a minimum diameter of 5 mm not completely removed by the diagnostic biopsy
• Patient planned for wide local excision and sentinel lymph node biopsy
• Adequate organ function on blood test
• Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
• Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.