Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer

Summary

This is an adaptive, open-label, randomised phase II trial that aims to evaluate the impact of 3 vs 6 cycles of first-line platinum-based chemotherapy followed by maintenance avelumab in the quality of life of patients with locally advanced or metastatic urothelial cancer. Initially, 224 eligible and evaluable patients (112 in each arm) will receive 3 cycles vs 6 cycles of 3-weekly gemcitabine plus cisplatin/carboplatin, followed by 2-weekly maintenance avelumab until disease progression or intolerable toxicities. Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy.

Timeline

Start

2021-12-16

Primary completion

2027-06-30

Completion

2027-12-22

Publications

• Powles T, Hussain SA, Climent MA, Carbonero IG, Molina-Cerrillo J, Puente J, Borrega P, Malik J, Dourthe LM, Jones R, Castellano D, Duran I, Loriot Y, Priyadarshini G, Szabados B, Jamal F, Wang YQ, Kotriwala N, Jackson-Spence F, Ackerman C, Grande E. Three versus six cycles of platinum-based chemotherapy followed by avelumab maintenance as first-line treatment for advanced urothelial cancer: the phase II DISCUS trial. Ann Oncol. 2026 Feb;37(2):250-259. doi: 10.1016/j.annonc.2025.10.011. Epub 2025 Oct 17.

Drugs

Indications