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@article{Pinato:2021:10.1186/s12885-021-08033-x,
author = {Pinato, D and Cortellini, A and Sukumaran, A and Cole, T and Pai, M and Habib, N and Spalding, D and Sodergren, M and Martinez, M and Dhillon, T and Tait, P and Thomas, R and Ward, C and Kocher, H and Yip, V and Slater, S and Sharma, R},
doi = {10.1186/s12885-021-08033-x},
journal = {BMC Cancer},
title = {PRIME-HCC: Phase Ib study of neoadjuvant ipilimumab and nivolumab prior to liver resection for hepatocellular carcinoma},
url = {http://dx.doi.org/10.1186/s12885-021-08033-x},
volume = {21},
year = {2021}
}

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TY  - JOUR
AB  - BackgroundAfter liver resection (LR), patients with hepatocellular cancer (HCC) are at high risk of recurrence. There are no approved anti-cancer therapies known to affect such risk, highlighting the acute need for novel systemic therapies to control the probability of disease relapse. Immunotherapy is expanding as a novel treatment option for HCC. Emerging data from cohort 4 of the CA209–040 study, which investigated the safety and preliminary efficacy of nivolumab/ipilimumab co-administration in advanced HCC, suggest that the combination can be delivered safely with an acceptable proportion of reversible grade 3–4 toxicities (27.1%) and a low discontinuation rate (2%) in patients with HCC. Here, we describe the design and rationale of PRIME-HCC, a two-part, multi-centre, phase Ib study to assess safety and bioactivity of the nivolumab/ipilimumab combination prior to LR in early-stage HCC.MethodsThe study involves an initial safety run-in phase (Part 1) to allow for preliminary safety characterisation within the first 6 patients enrolled and a subsequent expansion (Part 2). Ipilimumab will be administered once only on Day 1. Nivolumab will be administered on Day 1 and Day 22 (± 3 days) for a total of two 21-day cycles (i.e. 6 weeks of treatment). The primary objective of the study is to determine the safety and tolerability of the nivolumab/ipilimumab combination prior to LR. The secondary objective is to preliminarily characterize the efficacy of the combination prior to LR, including objective response rate (ORR) and pathologic response rates. Additional exploratory objectives include preliminary evidence of long-term disease control and to identify predictive correlates of response to the nivolumab/ipilimumab combination in HCC.DiscussionThe results of this study will help define the positioning of neoadjuvant nivolumab/ipilimumab combination in the perioperative management of HCC, with potential to improve survival outcom
AU  - Pinato,D
AU  - Cortellini,A
AU  - Sukumaran,A
AU  - Cole,T
AU  - Pai,M
AU  - Habib,N
AU  - Spalding,D
AU  - Sodergren,M
AU  - Martinez,M
AU  - Dhillon,T
AU  - Tait,P
AU  - Thomas,R
AU  - Ward,C
AU  - Kocher,H
AU  - Yip,V
AU  - Slater,S
AU  - Sharma,R
DO  - 10.1186/s12885-021-08033-x
PY  - 2021///
SN  - 1471-2407
TI  - PRIME-HCC: Phase Ib study of neoadjuvant ipilimumab and nivolumab prior to liver resection for hepatocellular carcinoma
T2  - BMC Cancer
UR  - http://dx.doi.org/10.1186/s12885-021-08033-x
UR  - http://hdl.handle.net/10044/1/88610
VL  - 21
ER  -

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