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Concomitant use of pembrolizumab and entinostat in adult patients with metastatic uveal melanoma (PEMDAC study): protocol for a multicenter phase II open label study.

Journal article
Authors Henrik Jespersen
Roger Olofsson Bagge
Gustav Ullenhag
Ana Carneiro
Hildur Helgadottir
Ingrid Ljuslinder
Max Levin
Charlotta All-Eriksson
Bengt Andersson
Ulrika Stierner
Lisa M Nilsson
Jonas A Nilsson
Lars Ny
Published in BMC cancer
Volume 19
Issue 1
Pages 415
ISSN 1471-2407
Publication year 2019
Published at Institute of Clinical Sciences, Department of Surgery
Institute of Clinical Sciences, Department of Oncology
Sahlgrenska Cancer Center
Pages 415
Language en
Keywords Administration, Intravenous, Administration, Oral, Antibodies, Monoclonal, Humanized, administration & dosage, therapeutic use, Antineoplastic Combined Chemotherapy Protocols, administration & dosage, therapeutic use, Benzamides, administration & dosage, therapeutic use, Drug Administration Schedule, Female, Humans, Male, Melanoma, drug therapy, Prospective Studies, Pyridines, administration & dosage, therapeutic use, Research Design, Treatment Outcome, Uveal Neoplasms, drug therapy
Subject categories Clinical Medicine


While recent years have seen a revolution in the treatment of metastatic cutaneous melanoma, no treatment has yet been able to demonstrate any prolonged survival in metastatic uveal melanoma. Thus, metastatic uveal melanoma remains a disease with an urgent unmet medical need. Reports of treatment with immune checkpoint inhibitors have thus far been disappointing. Based on animal experiments, it is reasonable to hypothesize that the effect of immunotherapy may be augmented by epigenetic therapy. Proposed mechanisms include enhanced expression of HLA class I and cancer antigens on cancer cells, as well as suppression of myeloid suppressor cells.The PEMDAC study is a multicenter, open label phase II study assessing the efficacy of concomitant use of the PD1 inhibitor pembrolizumab and the class I HDAC inhibitor entinostat in adult patients with metastatic uveal melanoma. Primary endpoint is objective response rate. Eligible patients have histologically confirmed metastatic uveal melanoma, ECOG performance status 0-1, measurable disease as per RECIST 1.1 and may have received any number of prior therapies, with the exception of anticancer immunotherapy. Twenty nine patients will be enrolled. Patients receive pembrolizumab 200 mg intravenously every third week in combination with entinostat 5 mg orally once weekly. Treatment will continue until progression of disease or intolerable toxicity or for a maximum of 24 months.The PEMDAC study is the first trial to assess whether the addition of an HDAC inhibitor to anti-PD1 therapy can yield objective anti-tumoral responses in metastatic registration number: NCT02697630 . (Registered 3 March 2016). EudraCT registration number: 2016-002114-50.

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