Durvalumab is a selective, high affinity, engineered human IgG1 monoclonal antibody that blocks programmed cell death ligand-1 (PD-L1) binding to PD- and CD80. PD-L1 inhibition with durvalumab in combination with other immunotherapies, including standard of care BCG, may improve response rate and duration of tumor response.
This trial is an open-label randomized, multicenter, global study to determine the efficacy and safety of Durvalumab + BCG (induction and maintenance) combination therapy, and durvalumab +BCG (induction only) combination therapy vs. BCG (induction and maintenance alone) in the treatment of patients with high risk non-muscle invasive urothelial carcinoma. All patients have undergone complete resection of papillary tumors and are BCG naïve. The study scheme is shown in figure 1.
The study will enroll approximately 1300 patients. The primary objective is to assess the efficacy of the various combination of treatments by measuring disease-free survival. The secondary endpoints are shown in table 1. Lastly, the inclusion and exclusion criteria are shown in table 2.
Figure 1 – Trial scheme:
Table 1 – Trial secondary endpoints:
Table 2 – Inclusion and exclusion criteria:
Presented by: Maria De Santis, MD medical oncologist and Chair of Section for Interdisciplinary Genito-Urinary Cancer Medicine at the Charité Medical University Hospital, Berlin, Germany.
Written By: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA