PEnile Cancer Radio- and Immunotherapy CLinical Exploration Study

Summary

Patients with advanced penile cancer have a poor prognosis (21% 2-year overall survival from moment of diagnosis) and high morbidity due to progressive locoregional disease. Translational studies show high rates of infiltrating immune cells and PD-L1 positivity, suggesting that immunotherapy may be beneficial in this disease. Atezolizumab, targeting PD-L1, is active in several cancer types and is generally well-tolerated. This study will investigate whether atezolizumab can be combined with radiotherapy to control locoregional lymph node disease. Furthermore, the activity of atezolizumab in advanced penile cancer patients will be investigated.

Timeline

Start

2018-09-25

Primary completion

2022-09-28

Completion

2023-09-15

Outcome

Missed primary endpoint

paper One-year PFS was 12.5% (95% CI, 5.0 to 31.3), which did not meet the study's primary end point. PMID 37487169 ↗

Publications

• de Vries HM, Rafael TS, Gil-Jimenez A, de Feijter JM, Bekers E, van der Laan E, Lopez-Yurda M, Hooijberg E, Broeks A, Peters D, Seignette IM, Pos FJ, Horenblas S, van Rhijn BWG, Jordanova ES, Brouwer OR, Schaake E, van der Heijden MS. Atezolizumab With or Without Radiotherapy for Advanced Squamous Cell Carcinoma of the Penis (The PERICLES Study): A Phase II Trial. J Clin Oncol. 2023 Nov 1;41(31):4872-4880. doi: 10.1200/JCO.22.02894. Epub 2023 Jul 24.

Drugs

Indications