At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (bladder, renal pelvis, ureter, or urethra); squamous or sarcomatoid differentiation or mixed cell types eligible if urothelial component present
- ✓Measurable disease by RECIST v1.1
- ✓Age ≥18 years
- ✓ECOG Performance Status 0, 1, or 2
- ✕Prior PD-(L)1 inhibitor treatment for advanced malignancy (neoadjuvant/adjuvant UC permitted)
- ✕Prior systemic therapy for locally advanced or metastatic UC except platinum-based regimen in neoadjuvant/adjuvant setting if >6 months since last cycle
- ✕Active CNS metastases (treated CNS metastases permitted if criteria met)
- ✕Pregnant and lactating females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised Phase II Study Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
In Brief
A Phase 2 clinical trial evaluating Avelumab for Urinary Bladder Neoplasms. Currently recruiting, targeting 320 participants across 3 sites in 3 countries.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy