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Clinical Trials in the EU / 2025-524077-16-00
Authorised, not yet recruiting Phase II

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

2025-524077-16-00 · tracked via the Priya Life Science EU tracker
Sponsor
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
Sponsor type
Patient organisation/association
Therapeutic area
Neoplasms
Decision date
12/05/2026
Enrollment target
144
Sites
Italy

Condition studied

metastatic urothelial carcinoma

Investigational medicinal product(s)

AVELUMAB

Every trial of Avelumab across our registers →

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

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.

Endpoint detail

Investigator-assessed PFS, Objective response rates (ORR), Duration of response (DR), Disease control rate (DCR) assessed per RECIST v1.1 by BICR and investigator., Safety: Adverse events (AEs) and laboratory abnormalities as graded by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, 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., Overall Survival (OS), 1-year PFS based on BICR assessment per RECIST v1.1.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524077-16-00 on CTIS ↗ ← All trials in the EU