Evidence map›Paper›PMID 34453044›Full record

Trial reportNature communications2021

The PEMDAC phase 2 study of pembrolizumab and entinostat in patients with metastatic uveal melanoma.

Lars Ny, Henrik Jespersen, Joakim Karlsson, Samuel Alsén, Stefan Filges, Charlotta All-Eriksson, Bengt Andersson, Ana Carneiro, Hildur Helgadottir, Max Levin and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02697630 (A Multicenter Phase II Open Label Study to Evaluate Efficacy of Concomitant Use of Pembrolizumab and Entinostat in Adult Patients With Metastatic Uveal Melanoma), which is not on this map. Cited by 117 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02697630 phase2completednot on this map

A Multicenter Phase II Open Label Study to Evaluate Efficacy of Concomitant Use of Pembrolizumab and Entinostat in Adult Patients With Metastatic Uveal Melanoma

TypeinterventionalSponsorVastra Gotaland RegionRan2018 to 2023Enrolled29ConditionsMetastatic Uveal MelanomaArmsPembrolizumab, Entinostat
3 · Its place in the literature

Who cites it

117 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Epigenetic plus cytokine therapy induces stem-like CD8Journal for immunotherapy of cancer · 2026
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57 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Lars Ny *Sahlgrenska Cancer Center, Department of Oncology, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden. lars.ny@oncology.gu.se.
Henrik Jespersen *Sahlgrenska Cancer Center, Department of Oncology, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID 0000-0002-6543-5369
Joakim KarlssonSahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Samuel AlsénSahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Stefan FilgesDepartment of Laboratory Medicine, Wallenberg Centre for Molecular and Translational Medicine, Department of Clinical Genetics and Genomics, Sahlgrenska Cancer Center, Institute of Biomedicine, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID 0000-0002-5994-6699
Charlotta All-ErikssonDepartment of Oncology, St. Erik Eye Hospital, Stockholm, Sweden.
Bengt AnderssonDepartment of Clinical Immunology and Transfusion Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
Ana CarneiroDepartment of Hematology Oncology and Radiation Physics, Skåne University Hospital, and Institute of Clinical Sciences, Lund University, Lund, Sweden.
Hildur HelgadottirDepartment of Oncology, Karolinska University Hospital, Stockholm, Sweden.
Max LevinSahlgrenska Cancer Center, Department of Oncology, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Ingrid LjuslinderDepartment of Oncology, Norrlands University Hospital, Umeå, Sweden.
Roger Olofsson BaggeSahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Vasu R SahSahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Ulrika StiernerSahlgrenska Cancer Center, Department of Oncology, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Anders StåhlbergDepartment of Laboratory Medicine, Wallenberg Centre for Molecular and Translational Medicine, Department of Clinical Genetics and Genomics, Sahlgrenska Cancer Center, Institute of Biomedicine, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID 0000-0003-4243-0191
Gustav UllenhagDepartment of Oncology, Uppsala University Hospital, Uppsala, Sweden.
Lisa M NilssonSahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
Jonas A NilssonSahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden. jonas.nilsson@perkins.org.au.ORCID 0000-0003-0346-6837

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Preclinical studies have suggested that epigenetic therapy could enhance immunogenicity of cancer cells. We report the results of the PEMDAC phase 2 clinical trial (n = 29; NCT02697630) where the HDAC inhibitor entinostat was combined with the PD-1 inhibitor pembrolizumab in patients with metastatic uveal melanoma (UM). The primary endpoint was objective response rate (ORR), and was met with an ORR of 14%. The clinical benefit rate at 18 weeks was 28%, median progression free survival was 2.1 months and the median overall survival was 13.4 months. Toxicities were manageable, and there were no treatment-related deaths. Objective responses and/or prolonged survival were seen in patients with BAP1 wildtype tumors, and in one patient with an iris melanoma that exhibited a UV signature. Longer survival also correlated with low baseline ctDNA levels or LDH. In conclusion, HDAC inhibition and anti-PD1 immunotherapy results in durable responses in a subset of patients with metastatic UM.Trial registration ClinicalTrials.gov registration number: NCT02697630 (registered 3 March 2016). EudraCT registration number: 2016-002114-50.

Indexed as

Antibodies, Monoclonal, HumanizedBenzamidesHumansMelanomaProgression-Free SurvivalPyridinesTumor Suppressor ProteinsUbiquitin ThiolesteraseUveal MelanomaUveal NeoplasmsAntibodies, Monoclonal, HumanizedBAP1 protein, humanBenzamidesentinostatpembrolizumabPyridinesTumor Suppressor ProteinsUbiquitin Thiolesterase

Identifiers

PMID34453044
PMCPMC8397717

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.