PETAL protocol: A phase Ib study of pembrolizumab after transarterial chemoembolization in hepatocellular carcinoma

Petros Fessas, Bernhard Scheiner, Antonio D'Alessio, Claudia A. M Fulgenzi, James Korolewicz, Caroline Ward, Paul Tait, Robert Thomas, Alessio Cortellini, Rohini Sharma, David J. Pinato

Research output: Contribution to journalReview articlepeer-review

Abstract

Transarterial chemoembolization (TACE) is the treatment of choice for intermediate-stage hepatocellular carcinoma (HCC). Recent data suggest that TACE may boost the efficacy of anti-PD-1 immunotherapy. The authors present the trial protocol for PETAL, a phase Ib study, which will assess the safety and bioactivity of pembrolizumab, an anti-PD-1 antibody, following TACE in HCC. After a run-in phase evaluating six patients to establish preliminary safety, up to 26 additional participants will be enrolled. Pembrolizumab will be administered three-Times weekly for 1 year or until progression, starting 30-45 days after TACE. The primary objective is to determine safety and the secondary objective is to preliminarily evaluate efficacy. Radiological responses will be evaluated every four cycles. Clinical Trial Registration: NCT03397654 (ClinicalTrials.gov.

Original languageEnglish
Pages (from-to)499-507
Number of pages9
JournalFuture Oncology
Volume19
Issue number7
DOIs
Publication statusPublished - 1 Mar 2023

Keywords

  • PD-1
  • hepatocellular carcinoma
  • immune checkpoint inhibitor
  • immunotherapy
  • pembrolizumab
  • transarterial chemoembolization

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