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

doi:10.2217/fon-2022-0916

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

Dipartimento di Medicina Traslazionale

Risultato della ricerca: Contributo su rivista › Articolo di review › peer 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.

Lingua originale	Inglese
pagine (da-a)	499-507
Numero di pagine	9
Rivista	Future Oncology
Volume	19
Numero di pubblicazione	7
DOI	https://doi.org/10.2217/fon-2022-0916
Stato di pubblicazione	Pubblicato - 1 mar 2023

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title = "PETAL protocol: A phase Ib study of pembrolizumab after transarterial chemoembolization in hepatocellular carcinoma",

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.",

keywords = "PD-1, hepatocellular carcinoma, immune checkpoint inhibitor, immunotherapy, pembrolizumab, transarterial chemoembolization",

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

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doi = "10.2217/fon-2022-0916",

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TY - JOUR

T1 - PETAL protocol

T2 - A phase Ib study of pembrolizumab after transarterial chemoembolization in hepatocellular carcinoma

AU - Fessas, Petros

AU - Scheiner, Bernhard

AU - D'Alessio, Antonio

AU - M Fulgenzi, Claudia A.

AU - Korolewicz, James

AU - Ward, Caroline

AU - Tait, Paul

AU - Thomas, Robert

AU - Cortellini, Alessio

AU - Sharma, Rohini

AU - Pinato, David J.

PY - 2023/3/1

Y1 - 2023/3/1

N2 - 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.

AB - 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.

KW - PD-1

KW - hepatocellular carcinoma

KW - immune checkpoint inhibitor

KW - immunotherapy

KW - pembrolizumab

KW - transarterial chemoembolization

UR - http://www.scopus.com/inward/record.url?scp=85159379478&partnerID=8YFLogxK

U2 - 10.2217/fon-2022-0916

DO - 10.2217/fon-2022-0916

M3 - Review article

SN - 1479-6694

VL - 19

SP - 499

EP - 507

JO - Future Oncology

JF - Future Oncology

IS - 7

ER -

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

Abstract

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