Urothelial CancerP-EVOLUTIONNCT06657157
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
An observational study of Urothelial Cancer, run by Comprehensive Cancer Center Munich (CCCM) at 4 sites in Germany.
Trial summary
The P-EVOLUTION trial is a prospective, multicenter, non-interventional observational study aimed at investigating peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin (EV) and pembrolizumab (P). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer
- How many people
- 80 participants
- Where
- 4 sitesGermany
- Study dates
- 22 Jan 2025to Feb 2027
- Phase
- Observational
- 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
Study population: Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich and TUM Munich.
Who may be able to join
- Adult patients, ≥18 years of age at the time of signing the informed consent form (ICF)
- Patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma
- Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve)
- Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information
Who cannot join
- Patients with contraindications for enfortumab vedotin and/or pembrolizumab
- Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors)
- Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors
- Patients who received neoadjuvant or adjuvant platinum-based chemotherapy <12 months ago
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
Department of Urology, University Hosptial Augsburg
Augsburg, Bavaria, 86156
Julie Steinestel, MD, +49 821 40001, Julie.Steinestel@uk-augsburg.de
- Recruiting
Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich
Munich, Bavaria, 81377
Jozefina Casuscelli, +49 89 4400 0, jozefina.casuscelli@med.uni-muenchen.de
- Recruiting
Department of Urology, Klinikum rechts der Isar, Technical University Munich
Munich, Bavaria, 81675
Kira Schüller, +49 89 4140 0, kira.shueller@tum.de
- Recruiting
Department of Urology, University Hospital of Würzburg
Würzburg, Bavaria, 97080
Anna Seitz, MD, +49 931 2010, Seitz_A3@ukw.de
About this study
Official title: 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.
The P-EVOLUTION trial is a prospective, multicenter, non-interventional observational study aimed at investigating peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin (EV) and pembrolizumab (P). Conducted at two German university hospitals, the study will track the incidence and severity of peripheral neuropathy, its impact on quality of life, and treatment regimen adjustments due to side effects. Approximately 80 patients are expected to be enrolled over one year.
- Conditions
- Urothelial Cancer
- Keywords
- enfortumab vedotin, Pembrolizumab, peripheral neuropathy, metastatic urothelial carcinoma, advanced urothelial carcinoma
- Medical subject headings
- Peripheral Nervous System Diseases, Carcinoma, Transitional Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peripheral neuropathy ≥ CTCAE grade 2
Incidence of peripheral neuropathy ≥ grade 2 at baseline, week 18, week 36, week 52, and at End of Treatment (defined as the administration of the last dose of EV/P) assessed by the Patient Neurotoxicity Questionnaire (PNQ)
Measured: baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)
Secondary outcomes (13)
Change of degree of sensory, motor and/or autonomic peripheral neuropathy applying the EORTC-CIPN20 questionnaire
A higher EORTC-CIPN20 score indicates a worse degree of neuropathy.
Measured: 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
An higher FACT/GOG-NTX score indicates a better QoL.
Measured: 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
A higher NPSI score indicates more neuropathic pain.
Measured: 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)
A higher ADS value indicates higher degree of depression.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
A higher nerve conduction velocity indicates a faster transmission of electrical signal along the nerve. And vice versa.
Measured: 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
A higher nerve conduction velocity indicates a faster transmission of electrical signal along the nerve. And vice versa.
Measured: 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
Measured: Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)
Changes in sensory perception using a monofilament test
Measured: Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)
Overall survival
defined as the time from administration of the first dose to date of death due to any cause
Measured: 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)
rw-PFS, defined as the time from the 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start22 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comprehensive Cancer Center Munich (CCCM)
- Sponsor type
- University, hospital or other
- Collaborators
- LMU Klinikum, Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany, Department of Urology, Augsburg University Hospital, Augsburg, Germany, Wuerzburg University Hospital
- Responsible party
- Principal investigator, Can Aydogdu, MD, Comprehensive Cancer Center Munich (CCCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657157
- Sponsor's protocol ID
- P-EVOLUTION
- Acronym
- P-EVOLUTION
- Status last verified
- Feb 2026
- First submitted
- 19 Oct 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06657157
- Acronym / sponsor ID
- P-EVOLUTION / P-EVOLUTION
- Conditions
- Urothelial Cancer
- Keywords
- enfortumab vedotin, Pembrolizumab, peripheral neuropathy, metastatic urothelial carcinoma, advanced urothelial carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Comprehensive Cancer Center Munich (CCCM)University, hospital or other
- Collaborators
- LMU Klinikum, Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany, Department of Urology, Augsburg University Hospital, Augsburg, Germany, Wuerzburg University Hospital
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Oct 2024 (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.
The P-EVOLUTION trial is a prospective, multicenter, non-interventional observational study aimed at investigating peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin (EV) and pembrolizumab (P). Conducted at two German university hospitals, the study will track the incidence and severity of peripheral neuropathy, its impact on quality of life, and treatment regimen adjustments due to side effects. Approximately 80 patients are expected to be enrolled over one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich and TUM Munich.
Key inclusion criteria (4 listed)
- Adult patients, ≥18 years of age at the time of signing the informed consent form (ICF)
- Patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma
- Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve)
- Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information
Key exclusion criteria (4 listed)
- Patients with contraindications for enfortumab vedotin and/or pembrolizumab
- Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors)
- Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors
- Patients who received neoadjuvant or adjuvant platinum-based chemotherapy <12 months ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of peripheral neuropathy ≥ CTCAE grade 2
Time frame: baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)
Incidence of peripheral neuropathy ≥ grade 2 at baseline, week 18, week 36, week 52, and at End of Treatment (defined as the administration of the last dose of EV/P) assessed by the Patient Neurotoxicity Questionnaire (PNQ)
13 secondary outcomes
Change of degree of sensory, motor and/or autonomic peripheral neuropathy applying the EORTC-CIPN20 questionnaire
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)
Changes in sensory perception using a monofilament test
Time frame: Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)
Overall survival
Time frame: 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)
Time frame: 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.
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 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Department of Urology, University Hosptial Augsburg
Augsburg, Germany
Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich
Munich, Germany
Department of Urology, Klinikum rechts der Isar, Technical University Munich
Munich, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Cancer, run by Comprehensive Cancer Center Munich (CCCM) at 4 sites in Germany.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of peripheral neuropathy ≥ CTCAE grade 2 (time frame: baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)). 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 24 Feb 2026.