RecruitingPhase 2NCT06892860

Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer

A Randomised Phase II Study Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer

Sponsor

Queen Mary University of London

Enrollment

320 participants

Start Date

Dec 16, 2021

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing whether 3 cycles versus 6 cycles of platinum-based chemotherapy before switching to a maintenance immunotherapy drug (avelumab) is equally effective in treating advanced urothelial cancer (cancer of the bladder, kidney lining, ureter, or urethra), with the aim of reducing chemotherapy exposure. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic urothelial cancer that cannot be removed by surgery - You have measurable disease on imaging - You are fit to receive gemcitabine plus cisplatin or carboplatin chemotherapy **You may NOT be eligible if...** - You have already received chemotherapy for your advanced cancer - Your kidneys are too impaired to receive certain chemotherapy agents - You have serious immune-related conditions or other health issues that make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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