Abstract 334TiP
Background
Radical nephroureterectomy (RNU) is the standardized treatment for non-metastatic high-risk UTUC. For patients with solitary kidney or renal insufficiency, kidney sparing therapy can be performed according to the specific conditions of patients without affecting survival. DV is comprised of a humanized immunoglobulin (Ig) G1 anti-HER2 monoclonal antibody conjugated with monomethyi auristatin E (MMAE) via a cleavable peptide linker. DV combined with Toripalimab has shown promising efficacy in patients with mUC (UTUC of 53.66%) regardless of HER2 expression, with ORR of 73.2% in all patients. (Xinan Sheng et al. ASCO 2023). This prospective study aims to evaluate the efficacy and safety of DV combined with Toripalimab as kidney-sparing therapy in selected patients with solitary kidney or renal insufficiency or bilateral multiple UTUC.
Trial design
This is a single-arm, multicenter clinical study of DV plus Toripalimab in patients with solitary kidney or renal insufficiency or bilateral UTUC (NCT06354231). The study will be conducted in accordance with the Good Clinical Practice (GCP) and about 20 participants will be enrolled in this study to evaluate the efficacy and safety of the combination of DV (2.0 mg/kg, intravenously administered every 2 weeks) and Toripalimab (3.0mg/kg, intravenously administered every 2 weeks). Participants will receive 6 cycles of DV and Toripalimab, who achieved CR/PR/SD were given kidney sparing surgery including endoscopic ablation to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of Toripalimab consolidation therapy. Main inclusion criteria: age ≥ 18 years, histologically confirmed UTUC, refusal or ineligibility for RNU, preoperative risk stratification was defined as high-risk UTUC. The primary endpoint is kidney-intact disease-free survival at 1 year (1-yr KIDFS) and the secondary endpoints including time to renal resection, disease-specific survival, overall survival, complete response rate at 6 month and safety. This trial is still open for recruiting and 3 patients have been enrolled.
Clinical trial identification
NCT06354231.
Legal entity responsible for the study
Fudan University Shanghai Cancer Center.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.