Urothelial Carcinoma (UC)ENDEAVORNCT07629700
Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR)
A study testing enfortumab vedotin (EV), PEMBROLIZUMAB (alone or when added to a regimen above) and Neuridase in people with Urothelial Carcinoma (UC) and Peripheral Nerve Disease, run by University of Florence.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma (UC), Peripheral Nerve Disease
- What is being tested?
- enfortumab vedotin (EV), PEMBROLIZUMAB (alone or when added to a regimen above) and Neuridase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Being tested
- enfortumab vedotin (EV), PEMBROLIZUMAB (alone or when added to a regimen above), Neuridase
- Medical subject headings
- Carcinoma, Transitional Cell, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enfortumab vedotin (EV)Drug
Standard-of-care enfortumab vedotin administered according to approved clinical practice.
PEMBROLIZUMAB (alone or when added to a regimen above)Drug
Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.
NeuridaseOther
Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.
| Study group | Role | What they receive |
|---|---|---|
| arm label | Experimental | 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. Receives: Drug: enfortumab vedotin (EV); Drug: PEMBROLIZUMAB (alone or when added to a regimen above); Other: Neuridase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Peripheral Neuropathy
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.
Measured: From baseline to 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Enfarma S.p.A.
- Responsible party
- Principal investigator, Giandomenico Roviello, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629700
- Sponsor's protocol ID
- ENDEAVOR
- Other IDs
- CE 30693_spe
- Acronym
- ENDEAVOR
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected during the study will not be made publicly available. Data sharing may be considered on reasonable request to the study investigators and in accordance with institutional policies, ethical approvals, and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07629700
- Acronym / sponsor ID
- ENDEAVOR / ENDEAVOR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Enfarma S.p.A.
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm label | Experimental | Drug: enfortumab vedotin (EV), Drug: PEMBROLIZUMAB (alone or when added to a regimen above), Other: NeuridaseNeuridase: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enfortumab vedotin (EV)Standard-of-care enfortumab vedotin administered according to approved clinical practice. | Drug | arm label |
| PEMBROLIZUMAB (alone or when added to a regimen above)Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice. | Drug | arm label |
| NeuridaseSupportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes. | Other | arm label |
Primary outcome
Incidence and Severity of Peripheral Neuropathy
Time frame: From baseline to 6 months after treatment initiation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data collected during the study will not be made publicly available. Data sharing may be considered on reasonable request to the study investigators and in accordance with institutional policies, ethical approvals, and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing enfortumab vedotin (EV), PEMBROLIZUMAB (alone or when added to a regimen above) and Neuridase in people with Urothelial Carcinoma (UC) and Peripheral Nerve Disease, run by University of Florence.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Antonuzzo, MD Phd, MD (055-5465353, lorenzo.antonuzzo@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Peripheral Neuropathy (time frame: From baseline to 6 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.