This protocol applies to patients with metastatic or unresectable urothelial carcinoma who are ineligible for cisplatin and who have progressed — or failed to achieve adequate disease control — on a first-line carboplatin-based regimen, and for whom enfortumab vedotin is contraindicated or not available.
Cisplatin ineligibility in this setting is driven by reduced kidney function (eGFR 30–60 mL/min) or ECOG performance status 2. Approximately 50% of patients with bladder cancer do not qualify for cisplatin-based chemotherapy. This protocol additionally addresses patients in whom enfortumab vedotin cannot be used — either due to a contraindication or because the agent is unavailable.
The previous line consisted of gemcitabine plus carboplatin, followed by maintenance avelumab in patients who achieved at least stable disease on chemotherapy. This protocol is indicated when that regimen did not achieve its targets — objective response or stable disease — and the next therapeutic step is required.
Subsequent management may involve an antibody-drug conjugate or, in patients whose tumours carry specific actionable molecular alterations, a targeted agent. Further options exist depending on clinical and tumour characteristics. The full protocol — including complete sequencing, eligibility criteria, and all available options — is available via the link below.