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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.

Jespersen, Henrik (författare)
University of Gothenburg,Gothenburg University,Göteborgs universitet,Sahlgrenska Cancer Center,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Bla Straket 2, S-41345 Gothenburg, Sweden,Sahlgrenska University Hospital
Olofsson Bagge, Roger (författare)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery
Ullenhag, Gustav (författare)
Uppsala University,Uppsala universitet,Experimentell och klinisk onkologi
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Carneiro, Ana (författare)
Lund University,Lunds universitet,Skåne University Hospital
Helgadottir, Hildur (författare)
Karolinska Univ Hosp, Dept Oncol, Karolinska Vagen, S-17176 Stockholm, Sweden,Karolinska University Hospital
Ljuslinder, Ingrid (författare)
Norrlands Univ Hosp, Dept Oncol, S-90185 Umea, Sweden,Norrland University Hospital
Levin, Max, 1969 (författare)
University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Bla Straket 2, S-41345 Gothenburg, Sweden,Sahlgrenska University Hospital
All-Eriksson, Charlotta (författare)
St Erik Eye Hosp, Polhemsgatan 50, S-11230 Stockholm, Sweden,St Erik Eye Hospital
Andersson, Bengt (författare)
Sahlgrens Univ Hosp, Dept Clin Immunol & Transfus Med, Guldhedsgatan 10, S-41345 Gothenburg, Sweden,Sahlgrenska University Hospital
Stierner, Ulrika, 1952 (författare)
University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Bla Straket 2, S-41345 Gothenburg, Sweden,Sahlgrenska University Hospital
Nilsson, Lisa M, 1976 (författare)
Gothenburg University,Göteborgs universitet,Sahlgrenska Cancer Center,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery
Nilsson, Jonas A, 1971 (författare)
Gothenburg University,Göteborgs universitet,Sahlgrenska Cancer Center,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery
Ny, Lars, 1967 (författare)
University of Gothenburg,Gothenburg University,Göteborgs universitet,Sahlgrenska Cancer Center,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Bla Straket 2, S-41345 Gothenburg, Sweden,Sahlgrenska University Hospital
Nilsson, Lisa M. (författare)
University of Gothenburg,Sahlgrenska University Hospital
Nilsson, Jonas A. (författare)
University of Gothenburg,Sahlgrenska University Hospital
Bagge, Roger Olofsson (författare)
University of Gothenburg,Sahlgrenska University Hospital
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BMC, 2019
2019
Engelska.
Ingår i: BMC cancer. - : BMC. - 1471-2407. ; 19:1
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • 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 UM.ClinicalTrials.gov registration number: NCT02697630 . (Registered 3 March 2016). EudraCT registration number: 2016-002114-50.

Ämnesord

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)

Nyckelord

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
Uveal melanoma
Metastatic
Immunotherapy
Programmed cell death 1 receptor
Pembrolizumab
Epigenetics
Histone deacetylase inhibitors
Entinostat

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