OncoMatch/Clinical Trials/NCT06892860
Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
Is NCT06892860 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Avelumab for urinary bladder neoplasms.
Treatment: Avelumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Metastatic disease required
unresectable locally advanced or metastatic urothelial carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: PD-(L)1 inhibitor
Exception: Treatment with PD-(L)-1 inhibitors in the neoadjuvant or adjuvant setting for UC are permitted.
Prior treatment with a PD-(L)-1 inhibitor for any advanced malignancy. Treatment with PD-(L)-1 inhibitors in the neoadjuvant or adjuvant setting for UC are permitted.
Cannot have received: systemic therapy
Exception: A platinum containing regimen (cisplatin or carboplatin) in the neoadjuvant or adjuvant setting if more than 6 months since last cycle have occurred. Patients who received adjuvant or neoadjuvant immune therapy for muscle invasive or non-muscle invasive disease are eligible.
Prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: a platinum containing regimen (cisplatin or carboplatin) in the neoadjuvant or adjuvant setting if more than 6 months since last cycle have occurred. Patients who received adjuvant or neoadjuvant immune therapy for muscle invasive or non-muscle invasive disease are eligible.
Lab requirements
Blood counts
Adequate haematologic and organ function as defined below
Kidney function
GFR <60 mL/min but ≥30 mL/min (measured by the Cockcroft-Gault formula or by local accepted standards). Subjects with a GFR ≥50 mL/min and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator's clinical judgement.
Liver function
Adequate haematologic and organ function as defined below
Cardiac function
NYHA Class III heart failure. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebral vascular accident/stroke within 6 months prior to enrolment, unstable arrhythmias, or unstable angina.
Adequate haematologic and organ function as defined below: GFR <60 mL/min but ≥30 mL/min... NYHA Class III heart failure.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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