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

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 chem

Trial Details

NCT ID
NCT06892860
Phase
PHASE2
Sponsor
Queen Mary University of London
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • Avelumab
Locations (sample)
  • Paris, France|48.85341,2.3488
  • Madrid, Spain|40.4165,-3.70256
  • London, United Kingdom|51.50853,-0.12574

Key Eligibility Criteria

  • Willing and able to provide written informed consent.
  • Ability to comply with the protocol, including but not limited to, the repeated completion of the EORTC QLQ-C30 questionnaires.
  • Age ≥ 18 years.
  • Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or u…

For full eligibility, visit ClinicalTrials.gov.

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