P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs).

• DOI: 10.1200/jco.2023.41.6_suppl.tps431
• Publication Date: 2023-03-14T15:22:32Z
• Authors: Danka Zebic; Martin R. Stockler; Andrew James Martin; Farzana D. Pashankar; Ben Tran; Danish Mazhar; Robert A Huddart; Matthew Wheater; Euan Thomas Walpole; Elaine Dunwoodie; Darren R. Feldman; Alison Jane Birtle; Amanda Gwendolyn ...; David Wyld; Fritha J. Hanning; Peter S. Grimison
• Keywords: Clinical endpoint; Chemotherapy regimen

TPS431 Background: Bleomycin, etoposide, and cisplatin (BEP) given 3-weekly x 4 remains standard 1st line chemotherapy for intermediate or poor risk metastatic GCT. Accelerating regimens by shortening the cycle length to 2-weekly improved cure rates in other cancers. P3BEP will determine effects of accelerated versus BEP this setting. This is a first international, randomized trial poor-risk GCT include adults children both sexes. Methods: open label, randomized, phase 3 conducted seamlessly 2-stages. The primary endpoint stage I (n=150) was complete response (CR); 2 (n=500) progression free survival at years (PFS2y). These sample sizes provide >80% power with two-sided type error rate 5% detect an absolute improvement 25% CR (stage 1) 7% PFS2y 2). target population males females aged 11 45 intermediate-or testis, ovary, retroperitoneum, mediastinum. Participants are (1:1) cycles (q3w) accelerated-BEP (q2w) 20mg/m D1-5, etoposide 100mg/m bleomycin 30 KIU weekly 12, pegylated G-CSF D6 filgrastim daily. Study assessments occur days after completing chemotherapy, 6 months from randomization, completion all post-chemotherapy treatments (e.g. surgery). Tumour baseline blood samples collected translational substudies. Progress: As Sept 2022, 226 participants have been recruited 24 ANZ sites, 17 UK sites (led Cambridge Clinical Trials Unit), 149 USA Children’s Oncology Group). planned interim analysis safety (n=76) identified no concerns. Stage showed sufficiently favorable results futility concerns, supporting ongoing recruitment. information: NCT02582697 .