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

Study ID Alternative Stable ID Type
EGAS00001005478 Other

Study Description

Patients with metastatic uveal melanoma (UM) have an abysmal prognosis. Preclinical studies have suggested that epigenetic therapy could enhance immunogenicity of cancer cells. Here we test if epigenetic therapy would enhance PD-1 immunotherapy in patients with metastatic UM. 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 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. Extensive genomics studies were performed using DNA/RNA and single cell sequencing and flow cytometry. Objective responses and prolonged survival were seen in three patients with BAP1 wildtype tumors, and in one patient with an iris melanoma that exhibited a UV signature. Longer survival also correlated with low ... (Show More)

Study Datasets 3 datasets.

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Dataset ID Description Technology Samples
DNA (exome) sequencing of uveal melanoma metastases.
Illumina NovaSeq 6000,NextSeq 500 107
RNA sequencing of uveal melanoma metastases.
Illumina NovaSeq 6000,NextSeq 500 22
Single-cell RNA and TCR sequencing of PBMC from patients with uveal melanoma.
Illumina MiSeq,NextSeq 500 16

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