Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR) (ENDEAVOR)
ENDEAVOR Study: A Prospective Exploratory Study Describing the Course of Peripheral Neuropathy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin in Combination With Pembrolizumab and Supportive Neuridase
his prospective exploratory study aims to describe the course of peripheral neuropathy in patients with locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin in combination with pembrolizumab and receiving supportive Neuridase.
Peripheral neuropathy is a common adverse event associated with enfortumab vedotin and may negatively affect treatment tolerability, quality of life, and treatment continuation. Neuridase is a non-pharmacological supportive product intended to support peripheral nervous system function; however, its role in this clinical setting has not yet been established.
Participants enrolled in this single-arm study will receive standard-of-care treatment with enfortumab vedotin plus pembrolizumab, together with supportive Neuridase according to clinical practice. The study will prospectively assess neuropathy symptoms and severity using clinical evaluations and patient-reported outcome measures, including quality-of-life questionnaires, over the course of treatment.
The objective of the study is to explore neuropathy patterns and treatment tolerability in this patient population.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Lorenzo Antonuzzo, MD Phd, MD
- Telefoonnummer: 055-5465353
- E-mail: lorenzo.antonuzzo@unifi.it
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
IInclusion Criteria:
- Age ≥18 years
- Histologically confirmed locally advanced or metastatic urothelial carcinoma
- Candidate for treatment with enfortumab vedotin in combination with pembrolizumab according to clinical practice
- Ability to provide written informed consent
- Adequate clinical conditions to participate in the study according to investigator judgment
Exclusion Criteria:
- Pre-existing severe peripheral neuropathy that may interfere with study assessments
- Contraindications to enfortumab vedotin or pembrolizumab according to clinical practice
- Known hypersensitivity to components of Neuridase
- Pregnancy or breastfeeding
- Any medical, psychiatric, or social condition that, in the investigator's judgment, may interfere with study participation or interpretation of results
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: arm label
Neuridase: Participants with locally advanced or metastatic urothelial carcinoma will receive standard-of-care enfortumab vedotin in combination with pembrolizumab together with supportive Neuridase according to the study protocol. Peripheral neuropathy symptoms, treatment tolerability, and patient-reported outcomes will be prospectively assessed during treatment. |
Standard-of-care enfortumab vedotin administered according to approved clinical practice.
Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.
Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence and Severity of Peripheral Neuropathy
Tijdsspanne: From baseline to 6 months after treatment initiation
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Incidence and severity of peripheral neuropathy will be prospectively assessed according to clinical evaluation and CTCAE criteria in patients receiving enfortumab vedotin plus pembrolizumab with supportive Neuridase.
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From baseline to 6 months after treatment initiation
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Neoplasmata
- Neuromusculaire aandoeningen
- Neoplasmata per histologisch type
- Neoplasmata, glandulair en epitheel
- Carcinoom
- Ziekten van het perifere zenuwstelsel
- Carcinoom, overgangscel
- Sociaaleconomische factoren
- Bevolkingskenmerken
- Demografie
- Familiekarakteristieken
- Burgerlijke staat
- pembrolizumab
- ENFORTUMAB VEDOTIN
- Enkele persoon
Andere studie-ID-nummers
- ENDEAVOR
- CE 30693_spe (Register-ID: CE Careggi)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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