ClinicaliQ Trial Snapshot
- Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer — Recruiting • Phase II • Oncology • NCT06892860.
- What is being tested: The optimal duration of platinum-based chemotherapy (3 vs 6 cycles) prior to maintenance avelumab immunotherapy in patients with advanced urothelial cancer, with primary focus on quality of life outcomes rather than survival alone.
- Patient eligibility overview: Adults with locally advanced or metastatic urothelial cancer who are treatment-Phase IIïve and fit enough for platinum-based chemotherapy, excluding those with significant comorbidities or prior systemic cancer therapy.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : 1. Willing and able to provide written informed consent. 2. Ability to comply with the protocol, including but not limited to, the repeated completion of the EORTC QLQ-C30 questionnaires. 3. Age ≥ 18 years. 4. Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous or sarcomatoid differentiation or mixed cell types are eligible but a component of urothelial cancer is required. 5. Measurable disease by RECIST v1.1. 6. Eligible for gemcitabine/ cisplatin or gemcitabine/carboplatin. The following criteria are established for the use of carboplatin (patients not fulfilling the following carboplatin criteria should be considered for gemcitabine/ cisplatin): 1. GFR
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.