Maintenance AVElumab after SECond line platinum-based chemotherapy for metastatic urothelial carcinoma: AVESEC trial – GOIRC-02-2025

INTERVENTION: Product Name: AVELUMAB, Product Code:SUB180078, Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR INFUSION, Other descriptive name: Bavencio , Strength: CONDITION: metastatic urothelial carcinoma ; MedDRA version: 27.0Level: LLTClassification code: 10090000Term: Urothelial carcinoma metastatic Class: 100000004864 Therapeutic area: Diseases [C] ‐ Neoplasms [C04] PRIMARY OUTCOME: Main Objective: The primary objective is to assess the efficacy in terms of blinded independent central review (BICR) progression‐free survival (PFS) of maintenance avelumab 800 mg IV Q2W vs best supportive care (BSC) in patients with partial/complete response or stable disease to second‐line platinum‐based chemotherapy with advanced or metastatic urothelial carcinoma progressed to first‐line pembrolizumab plus enfortumab vedotin Primary end point(s): Comparison between treatment arms will be performed using a one‐sided log‐rank test, and the treatment effect will be quantified using the hazard ratio (HR) estimated from a Cox proportional hazards model, along with corresponding confidence intervals. Secondary Objective: To determine the benefit in terms of overall survival (OS) of maintenance avelumab vs BSC, To determine the benefit in terms of PFS assessed by investigator of maintenance avelumab vs BSC., To evaluate the anti‐tumor activity of maintenance avelumab vs BSC according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1., To evaluate the overall safety profile of maintenance avelumab vs BSC., To assess the effect of maintenance avelumab vs BSC on patients reported outcomes (PROs) using 2 validated instruments (FBlSI and EQ‐5D). SECONDARY OUTCOME: Secondary end point(s):1‐year PFS based on BICR assessment per RECIST v1.1. Secondary end point(s):Disease control rate (DCR) assessed per RECIST v1.1 by BICR and investigator. Secondary end point(s):Duration of response (DR) Secondary end point(s):Investigator‐assessed PFS Secondary end point(s):Objective response rates (ORR) Secondary end point(s):Overall Survival (OS) Secondary end point(s):Patient‐Reported Outcomes: patient‐reported bladder cancer symptom, functioning, global quality of life (QOL), and Time to Deterioration (TTD) using the NCCN‐ FACT FBlSI; health status using the EQ‐5D. Secondary end point(s):Safety: Adverse events (AEs) and laboratory abnormalities as graded by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 INCLUSION CRITERIA: Histologically or cytologically‐confirmed diagnosis of metastatic or locally advanced unresectable urothelial carcinoma of the bladder or upper tract with predominant transitional cell carcinoma., If in fertile age, must agree to use highly effective methods of contraception (licensed hormonal methods for female patients and condom for male patients) throughout the study and for at least 30 days after the last dose., Male or female =18 years., Signed informed consent documenting that the patient has been informed on all the aspects of the study., Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion/exclusion criteria, Have received first‐line of therapy consisting in enfortumab vedotin plus pembrolizumab and second‐line of therapy with cisplatin or carboplatin plus gemcitabine (at least 3 cycles). Adjuvant or neoadju