NOT YET RECRUITING
NCT07883759
Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study.
This phase II trial examine whether neoadjuvant PD-1 blockade will achieve a pathological response with manageable toxicity in stage IIB/IIC melanoma.
Patients with histologically confirmed AJCC (8th edition) clinical stage IIB (T3b, T4a), or IIC (T4b) primary cutaneous melanoma from a partial biopsy, with residual macroscopic disease without metastases will be included. They will be treated with 2 infusions of Pembrolizumab followed by surgery and adjuvant treatment.
The primary objective is to assess the pathological response of the primary tumor. Secondaries objectives include the evaluation of efficacy and safety as well as exploratory biomarkers analysis.
Gender: All
Ages: 18 Years - Any
Stage IIB Melanoma
Stage IIC Melanoma