Peripheral Neuropathy in Patients Receiving Pembrolizumab and Enfortumab Vedotin as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.

简要总结

主要结局

次要结局

• Changes in sensory perception using a monofilament test(Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P))
• Change of degree of sensory, motor and/or autonomic peripheral neuropathy applying the EORTC-CIPN20 questionnaire(Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P))
• Change of Quality of life (QoL) applying the FACT/GOG-NTX questionnaire(Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P))
• Change of neuropathic pain applying the Neuropathic Pain Symptom Inventory (NPSI) questionnaire(Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P))
• Change of depression based on the Allgemeine Depressionsskala (ADS)(Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P))
• Time to onset of peripheral neuropathy ≥ CTCAE grade 2(From the administration of the first dose of EV/P to the end of treatment (defined as the administration of the final dose of EV/P), which is expected to occur after approximately one year.)
• Number of dose reductions, delays or treatment discontinuation due to peripheral neuropathy or other adverse events(From the administration of the first dose of EV/P to the end of treatment (defined as the administration of the final dose of EV/P), which is expected to occur after approximately one year.)
• Number of cycles of EV + P administered(From the administration of the first dose of EV/P to the end of treatment (defined as the administration of the final dose of EV/P), which is expected to occur after approximately one year.)
• Change in nerve conduction studies, as measured by neurography, in the right tibial (motor) nerve(Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P))
• Change in nerve conduction studies, as measured by neurography, in the right sural (sensory) nerve(Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P))
• Changes in hand force as measured with a Martin-Vigorimeter(Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P))
• Overall survival(From administration of first dose to date of death of any cause, assessed for up to 60 months)
• real world Progression free survival (rw-PFS)(From administration of the first dose of EV/P to the first documented disease progression, as determined by the investigator, or to death from any cause, whichever occurs first, assessed up to 60 months.)