Urothelial CancerP-EVOLVENCT07870577
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma
An observational study of Urothelial Cancer and MIBC, run by Comprehensive Cancer Center Munich (CCCM) at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer, MIBC
- How many people
- 79 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Jun 2026to Dec 2028
- 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, TUM Munich, and Krankenhaus Barmherzige Bürde 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 muscle-invasive urothelial carcinoma
- Patients who have not received any prior systemic treatment for muscle-invasive bladder cancer
- Patients who are eligible to receive enfortumab ve-dotin and pembrolizumab according to the respec-tive medicinal product information
Who cannot join
- Patients with contraindications to enfortumab ve-dotin and/or pembrolizumab
- Patients who have received prior systemic therapy for muscle-invasive bladder cancer (e.g. platinum-based chemotherapy, immune checkpoint inhibitors)
- Patients who have previously been treated with en-fortumab vedotin, other MMAE-based antibody-drug conjugates, or PD-(L)1 inhibitors
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Department of Urology, Krankenhaus Barmherzige Brüder
Munich, Bavaria, 80639
Tobias Hauser, MD, 0049 89 17970, Tobias.Hauser@barmherzige-muenchen.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, MD, +49 89 4140 0, kira.shueller@tum.de
About this study
Official title: Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.
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.
Read more
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.
- Conditions
- Urothelial Cancer, MIBC
- Keywords
- enfortumab vedotin, Pembrolizumab, peripheral neuropathy, muscle-invsive bladder cancer
- Medical subject headings
- Peripheral Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, within 14 days before initiation of neoadjuvant therapy, to end of treatment (EOT) ±14 days
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (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
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comprehensive Cancer Center Munich (CCCM)
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany, Department of Urology, Krankenhaus Barmherzige Brüder, Munich, Germany, Department of Urology, LMU University Hospital, Munich, Germany
- Responsible party
- Principal investigator, Can Aydogdu, MD, Comprehensive Cancer Center Munich (CCCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870577
- Sponsor's protocol ID
- P-EVOLVE
- Acronym
- P-EVOLVE
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.
- ClinicalTrials.gov ID
- NCT07870577
- Acronym / sponsor ID
- P-EVOLVE / P-EVOLVE
- Conditions
- Urothelial Cancer, MIBC
- Keywords
- enfortumab vedotin, Pembrolizumab, peripheral neuropathy, muscle-invsive bladder cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Comprehensive Cancer Center Munich (CCCM)University, hospital or other
- Collaborators
- Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany, Department of Urology, Krankenhaus Barmherzige Brüder, Munich, Germany, Department of Urology, LMU University Hospital, Munich, Germany
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Oct 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.
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.
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, TUM Munich, and Krankenhaus Barmherzige Bürde 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 muscle-invasive urothelial carcinoma
- Patients who have not received any prior systemic treatment for muscle-invasive bladder cancer
- Patients who are eligible to receive enfortumab ve-dotin and pembrolizumab according to the respec-tive medicinal product information
Key exclusion criteria (3 listed)
- Patients with contraindications to enfortumab ve-dotin and/or pembrolizumab
- Patients who have received prior systemic therapy for muscle-invasive bladder cancer (e.g. platinum-based chemotherapy, immune checkpoint inhibitors)
- Patients who have previously been treated with en-fortumab vedotin, other MMAE-based antibody-drug conjugates, or PD-(L)1 inhibitors
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
Change From Baseline to End of Treatment in Sensory Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20 Sensory Subscale
Time frame: Baseline, within 14 days before initiation of neoadjuvant therapy, to end of treatment (EOT) ±14 days
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.
18 secondary outcomes
Change From Baseline Over Time in Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20
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
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
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
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
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
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
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
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
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
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)
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
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
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Sural Nerve Distal Latency
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Sural Nerve Conduction Velocity
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Tibial Nerve Motor Response Amplitude
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Tibial Nerve Distal Latency
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
Change From Baseline in Right Tibial Nerve Conduction Velocity
Time frame: Baseline, within 14 days before radical cystectomy, and EOT (±14 days)
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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Urothelial Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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, Krankenhaus Barmherzige Brüder
Munich, 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
3 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 and MIBC, run by Comprehensive Cancer Center Munich (CCCM) at 3 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 3 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change From Baseline to End of Treatment in Sensory Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20 Sensory Subscale (time frame: Baseline, within 14 days before initiation of neoadjuvant therapy, to end of treatment (EOT) ±14 days). 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 13 Oct 2026.