An observational study in Urothelial Cancer and MIBC, sponsored by Comprehensive Cancer Center Munich (CCCM). Recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Comprehensive Cancer Center Munich (CCCM) · Observational
P-EVOLVE is a prospective, multicenter, non-interventional observational study in adults with muscle-invasive urothelial carcinoma who receive perioperative treatment with enfortumab vedotin and pembrolizumab as part of routine clinical care.
The study is designed to describe how peripheral neuropathy develops and changes during treatment and whether symptoms persist at the end of treatment. Peripheral neuropathy will be assessed using patient-reported questionnaires, standardized neurological examinations, and nerve conduction studies. The study will also assess neuropathic pain, neurotoxicity-related quality of life, depressive symptoms, and changes in taste and smell. Objective gustatory function will be evaluated using standardized Taste Strip testing.
Study assessments will be performed before treatment, during the neoadjuvant and adjuvant treatment phases, around radical cystectomy, and at the end of treatment. Participation in the study does not determine whether treatment is started or how treatment is given. All anticancer treatment decisions remain part of routine clinical care.
The study aims to improve understanding of the onset, severity, longitudinal course, and persistence of peripheral neuropathy associated with perioperative enfortumab vedotin and pembrolizumab and to compare patient-reported symptoms with objective neurological and neurophysiological findings.
1,006 studies on the registry are indexed under Peripheral Nervous System Diseases; 179 are open to participants now.
This study's planned enrollment of 79 is below the median of 90 across 191 observational studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Comprehensive Cancer Center Munich (CCCM) is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich, TUM Munich, and Krankenhaus Barmherzige Bürde Munich.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Change From Baseline to End of Treatment in Sensory Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20 Sensory Subscale
Change from baseline to end of treatment (EOT) in the sensory subscale score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20). The sensory subscale is scored according to the EORTC scoring manual and linearly transformed to a 0 to 100 scale, with higher scores indicating greater peripheral neuropathy symptom burden. The individual change score is calculated as the EOT score minus the baseline score.
Time frame: Baseline, within 14 days before initiation of neoadjuvant therapy, to end of treatment (EOT) ±14 days
Change From Baseline Over Time in Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20
Longitudinal change in peripheral neuropathy symptoms assessed using the sensory, motor, and autonomic subscales of the EORTC QLQ-CIPN20. Subscale scores are calculated according to the EORTC scoring manual and transformed to a 0 to 100 scale, with higher scores indicating greater peripheral neuropathy symptom burden. Change from baseline will be evaluated at each post-baseline assessment.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days
Change Over Time in Peripheral Neuropathy Assessed by the Patient Neurotoxicity Questionnaire
Change and longitudinal course of patient-reported peripheral neuropathy assessed using the Patient Neurotoxicity Questionnaire (PNQ). The PNQ evaluates sensory and motor neurotoxicity using five ordered response categories from A to E. Increasing response categories indicate greater symptom severity and functional impairment.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days
Change From Baseline Over Time in Neuropathic Pain Assessed by the Neuropathic Pain Symptom Inventory
Change and longitudinal course of neuropathic pain assessed using the Neuropathic Pain Symptom Inventory (NPSI). The NPSI total score will be assessed at each scheduled time point, and change from baseline will be evaluated at post-baseline assessments and at EOT. The NPSI consists of 12 items assessing different characteristics of neuropathic pain, with symptom intensity items rated on an 11-point scale from 0 to 10.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days
Change From Baseline in Neuropathy-Related Quality of Life Assessed by the FACT/GOG-NTX
Change and longitudinal course of neuropathy-related patient-reported outcomes assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire. The FACT/GOG-NTX total score will be assessed during treatment, with change from baseline to EOT included as a prespecified endpoint.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days
Change From Baseline in Depressive Symptoms Assessed by the Allgemeine Depressionsskala
Change and longitudinal course of depressive symptoms assessed using the Allgemeine Depressionsskala (ADS). The ADS total score will be assessed during treatment, with change from baseline to EOT included as a prespecified endpoint.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days
Change Over Time in Patient-Reported Taste Alteration Assessed by the Patient-Generated Subjective Global Assessment
Change in patient-reported taste alteration assessed using the Patient-Generated Subjective Global Assessment (PG-SGA). Taste alteration is captured as a patient-reported symptom within the PG-SGA and will be evaluated longitudinally over the treatment period.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days
Change Over Time in Patient-Reported Taste and Smell Disturbances Assessed by the CCC MünchenLMU Taste and Smell Questionnaire
Change and longitudinal course of patient-reported taste and smell disturbances assessed using the Fragebogen zu Geschmack und Geruch developed by the Comprehensive Cancer Center MünchenLMU. The questionnaire assesses the presence and onset of taste and smell disturbances, persistence of abnormal taste, changes in sweet, sour, salty, and bitter taste perception, changes in smell, severity of abnormal sensations, and their perceived impact on quality of life.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days
Change From Baseline Over Time in Objective Gustatory Function Assessed by the Taste Strip Test
Longitudinal change in objective gustatory function assessed using a standardized Taste Strip test covering the four basic taste qualities of sweet, sour, salty, and bitter. Recorded parameters include the total taste score, defined as the number of correctly identified taste strips; taste-specific scores for sweet, sour, salty, and bitter; and classification of gustatory function as normogeusia, hypogeusia, or ageusia according to established reference values. Lower total or taste-specific scores indicate greater impairment of gustatory function.
Time frame: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; week 21 of adjuvant therapy ±14 days; and EOT ±14 days
Change From Baseline in Modified Medical Research Council (MRC) Sum Score
Change from baseline in muscle strength as assessed using the modified Medical Research Council (MRC) sum score. The MRC assessment evaluates muscle strength, with greater muscle strength reflected by higher individual muscle strength ratings.
Time frame: Baseline, within 14 days before radical cystectomy, start of adjuvant therapy (±14 days), Week 21 of adjuvant therapy (±14 days), and EOT (±14 days)
Change From Baseline in Hand Grip Strength Assessed by Martin Vigorimeter
Change from baseline in hand grip strength as assessed using a Martin Vigorimeter. Grip strength measurements will be compared with the baseline measurement to evaluate changes in muscle strength over the course of treatment.
Time frame: Baseline, within 14 days before radical cystectomy, start of adjuvant therapy (±14 days), Week 21 of adjuvant therapy (±14 days), and EOT (±14 days)
Change From Baseline in Modified Toronto Clinical Neuropathy Score (TCNS)
Change from baseline in peripheral neuropathy severity as assessed using the modified Toronto Clinical Neuropathy Score (TCNS). The modified TCNS evaluates clinical signs and symptoms of peripheral neuropathy, with changes from baseline used to assess development or progression of neuropathy.
Time frame: Baseline, within 14 days before radical cystectomy, start of adjuvant therapy (±14 days), Week 21 of adjuvant therapy (±14 days), and EOT (±14 days)
Change From Baseline in Cutaneous Sensory Function Assessed by Semmes-Weinstein Monofilament Test
Change from baseline in cutaneous sensory function as assessed using the Semmes-Weinstein monofilament test. The test assesses the ability to perceive standardized monofilament stimulation and is used to evaluate changes in peripheral sensory function.
Time frame: Baseline, within 14 days before radical cystectomy, start of adjuvant therapy (±14 days), Week 21 of adjuvant therapy (±14 days), and EOT (±14 days)
Change From Baseline in Right Sural Nerve Sensory Response Amplitude
Change from baseline in sensory response amplitude of the right sural nerve as assessed by nerve conduction studies. Sensory response amplitude is used as an electrophysiological measure of peripheral sensory nerve function.
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Sural Nerve Distal Latency
Change from baseline in distal latency of the right sural nerve as assessed by nerve conduction studies. Distal latency reflects the time required for an electrical impulse to produce a measurable sensory nerve response.
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Sural Nerve Conduction Velocity
Change from baseline in nerve conduction velocity of the right sural nerve as assessed by nerve conduction studies. Nerve conduction velocity reflects the speed of electrical impulse transmission along the sensory nerve.
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Tibial Nerve Motor Response Amplitude
Change from baseline in motor response amplitude of the right tibial nerve as assessed by nerve conduction studies. Motor response amplitude is used as an electrophysiological measure of peripheral motor nerve function.
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Tibial Nerve Distal Latency
Change from baseline in distal latency of the right tibial nerve as assessed by nerve conduction studies. Distal latency reflects the time required for an electrical impulse to produce a measurable motor nerve response.
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Tibial Nerve Conduction Velocity
Change from baseline in nerve conduction velocity of the right tibial nerve as assessed by nerve conduction studies. Nerve conduction velocity reflects the speed of electrical impulse transmission along the motor nerve.
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Peripheral Nervous System Diseases →
Comprehensive Cancer Center Munich (CCCM)