Immunotherapeutic treatment with Pembrolizumab (antibody) in melanoma patients at high risk of recurrence after complete surgical resection

Update Il y a 4 ans
Reference: EUCTR2014-004944-37

Woman and Man

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Extract

- To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves recurrence-free survival, as compared to placebo in high-risk patients with complete resection of Stage IIIA (>1 mm metastasis), IIIB and IIIC melanoma. - To prospectively assess whether in the subgroup of patients with PD-L1-positive tumor expression, pembrolizumab improves recurrence-free survival as compared to placebo.


Inclusion criteria

  • Stage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2010): Stage IIIA with metastasis > 1 mm; any Stage IIIB or IIIC (no in-transit metastases)