This study represents an innovative opportunity in the treatment of metastatic urothelial carcinoma
Histologically or cytologically-confirmed diagnosis of metastatic or locally advanced unresectable urothelial carcinoma of the bladder or upper tract with predominant transitional cell carcinoma.
Have received first-line of therapy consisting in enfortumab vedotin plus pembrolizumab and second-line of therapy with cisplatin or carboplatin plus gemcitabine (at least 3 cycles). Adjuvant or neoadjuvant chemotherapy is allowed if completed by >12 months.
Have not progressed per RECIST v1.1 guidelines (stable disease, partial response, complete response) following completion of 3-6 cycles of second-line chemotherapy.
Have measurable disease by RECIST v1.1 as assessed by the investigator.
Patients whose disease progressed by RECIST v1.1 on second-line chemotherapy for urothelial cancer.
Prior grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) toxicity from an immune-checkpoint inhibitor (thyroid toxicity excluded).
Persisting toxicity related to prior therapy (CTCAE Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable
Patients with known symptomatic central nervous system (SNC) metastases requiring steroids. Patients are eligible if treatment (radiation or surgery) for SNC metastases has been completed by at least 4 weeks before first study dose and have recovered from acute effects of treatment and are neurologically stable.
Parallel
Avelumab 800 mg flat-dose IV
DrugAvelumab 800 mg flat-dose IV every 2 weeks
Primary Endopoint
1-year PFS based on BICR assessment per RECIST v1.1
Secondary Endpoint
Overall Survival (OS)
Secondary Outcome
Investigator-assessed PFS
Secondary Outcome
Objective response rates (ORR)
Secondary Outcome
Duration of response (DR)
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