Transitional Cell Cancer of Renal Pelvis and UreterPhase 3UCM301NCT04620239
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
A Phase 3 study testing padeliporfin VTP in people with Transitional Cell Cancer of Renal Pelvis and Ureter, run by Steba Biotech S.A. at 18 sites in 5 countries.
Trial summary
This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Cancer of Renal Pelvis and Ureter
- What is being tested?
- padeliporfin VTP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 22 Mar 2021to 1 Aug 2028
- Phase
- Phase 3
- 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
- Male and female patients 18 years or older
- Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
- New or recurrent low-grade, non-invasive UTUC disease
- Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility.
- Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces,renal pelvis or in the ureter of the ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length)
- Karnofsky Performance Status ≥ 50%
Show all 12Show fewer
- Adequate organ function defined at baseline as:
- ANC ≥1,000/ μl,
- Platelets ≥75,000/ μl, Hb ≥9 g/dl,
- INR ≤ 2
- Estimated glomerular giltration rate (eGFR) ≥30 ml/min (using CKD-EPI Method)
- Total serum bilirubin <3 mg/dL, AST/ALT ≤5× upper limit of normal
Who cannot join
- Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
- Carcinoma in situ (CIS) current or previous in the upper urinary tract
- History of invasive T2 or higher urothelial cancer in past 2 years
- Participation in another clinical study involving an investigational product within 1 month before study entry
- BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
- Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment
Show all 11Show fewer
- Prohibited medication that could not be adjusted or discontinued prior to study treatment
- Patients with photosensitive skin diseases or porphyria
- Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary or liver disease or current heavy smoker that, in the opinion of the study investigator, would make the patient a poor candidate for the study
- Pregnant or breast-feeding women.Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry.
- Men and women of reproductive potential not willing to observe conventional and effective birth control for the duration of treatment and for 90 days following the last padeliporfin VTP treatment.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States12 sites
Albany Medical College
Albany, New York, 12208
Emory University Hospital
Atlanta, Georgia, 30322
The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
The Ohio State University (OSU)
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of California - Irvine Medical Center
Irvine, California, 92868
Keck School of Medicine at USC Medical Center
Los Angeles, California, 90033
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Washington
Seattle, Washington, 98195
France2 sites
CHU de Lille - Hopital Claude Huriez
Lille, 59037
HCL Hopital Edouard Herriot
Lyon, 69437
Spain2 sites
Hospital Universitario de A Coruña
A Coruña, 15006
Hospital Universitario Vall d'Hebron
Barcelona, 08035
About this study
Official title: Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (Padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer
This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment
Read the detailed description
Induction Treament Phase: Patients entered in the study will undergo an induction treatment phase consisting of 1-3 padeliporfin VTP treatments provided 4 weeks (28 +/-3 days) apart. The goal of this induction treatment phase will be to achieve Complete Response (CR) in the involved ipsilateral tract system. During this phase, patients will be treated with padeliporfin VTP to visually identified tumor sites in the calyces, renal pelvis and/or ureter and subsequently examined endoscopically at 28 +/- 3 days post treatment to determine whether the treatment was successful. If CR is not achieved, an additional two treatments of padeliporfin VTP are permitted 28 +/- 3 days apart for a total of up to 3 treatments during the induction treatment phase. The Primary Response Evaluation (PRE) will be performed 28 +/- 3 days after the last VTP treatment, to determine if the treatment was successful at achieving CR defined as: absence of visible tumor on endoscopy, negative urinary cytology by instrumented collection, and no evidence of tumor on biopsy (if feasible). Patients undergoing extirpative surgery of any part of the ipsilateral kidney or ureter for indications related to urothelial cancer will be considered as no longer having CR. If CR is not achieved after 3 treatments with padeliporfin VTP the treatment will be considered unsuccessful and the patient will be discontinued from the Treatment Phases.
Maintenance Treatment Phase: Patients achieving CR at the induction treatment phase will be allowed into the maintenance treatment phase of the study. The patients will then be followed over a period of 12 months post PRE, to assess the duration of response and its safety, and to provide planned maintenance treatment.
Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable as defined by the following criteria: low-grade tumors with the largest tumor (index tumor) betwen 5 mm and 15 mm in diameter, in up to 2 anatomical locations in the calyces, renal pelvis or the ureter with ureter involvement in one anatomical location with no more than 20 mm of contiguous ureteral length). Patients with treatable tumor recurrence post Induction Treatment Phase would be considered as no longer having 'complete response in the entire ipsilateral kidney' and time to recurrence will be recorded. Patients undergoing extirpative surgery of any part of the ipsilateral kidney or ureter for indications related to urothelial cancer will be considered as no longer having CR and time to this event will be recorded.
Long Term Follow-up Phase: Patients completing the 12 months of the maintenance treatment phase of the study, could be followed for an additional 48 months to monitor for disease related outcomes and VTP treatment related adverse events with the specific duration depending on the patient's response to treatment. No additional padeliporfin VTP treatment will be administered during this phase. Patients completing the maintenance phase of the study who are in CR in V3 will undergo additional assessments 18 and 24 months (+/- 1 month) post-PRE and annually thereafter and for up to 5 years post PRE or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.
- Being tested
- padeliporfin VTP
- Keywords
- UTUC, Low Grade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
padeliporfin VTPDrug
Also called WST11
During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| padeliporfin VTP | Experimental | Induction Treatment phase:1-3 padeliporfin VTP treatments provided 4 weeks (28 +/-3 days) apart.
Maintenance Treatment Phase: Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable. Receives: Drug: padeliporfin VTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter
Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response.
- Complete Response will be defined as absence of disease based on:
- absence of visual tumor on endoscopy
- no evidence of tumor on biopsy (if feasible)
- negative urinary cytology by instrumented collection
Measured: 28 +/- 3 days post last treatment
Secondary outcomes (17)
Duration of response at the entire ipsilateral kidney
The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on:
- instrumented cytology
- visually on endoscopy
- biopsy pathology (if feasible) as will be measured at the 12 months maintenance treatment visit post PRE
Measured: 12 months post PRE
Duration of response at the entire ipsilateral kidney
The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on:
- instrumented cytology
- visually on endoscopy
- biopsy pathology (if feasible) as will be measured at the 3, 6, 9 months maintenance treatment visits post PRE
Measured: 3, 6, 9 months post PRE
Duration of response at the Treatment Area of the ipsilateral kidney
Duration of response at the Treatment Area of the ipsilateral kidney will be defined as absence of disease in the ipsilateral Treatment Area, based on:
- instrumented cytology
- visually on endoscopy
- biopsy pathology (if feasible) as will be measured at the 3, 6, 9, and 12 months maintenance treatment visits post PRE
Measured: 3, 6, 9, and 12 months post PRE
Overall renal function
Overall renal functional outcome will be measured at the 6 and 12 months maintenance treatment visits post PRE, and will be evaluated by comparing pre-treatment and 12-month estimated glomerular filtration rate (eGFR), calculated from serum creatinine levels, using the CKD-Epi method including:
- Absolute change in eGFR as well as categories of CKD will be utilized based on KDIGO 2012 criteria
- Description will include change in eGFR, change in CKD stage/risk category
Measured: 6 and 12 months post PRE
Kidney organ loss or preservation
Kidney organ loss or preservation will be recorded at each maintenance treatment visit post PRE at 3, 6, 9, and 12 months Maintenance Treatment visits, and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss.
Measured: 3, 6, 9, and 12 months post PRE
Pathological evaluation of response
PathologicalPathological evaluation of response will be performed in kidney tissue of patients that will undergo kidney surgical removal (kidney sparing, or radical nephroureterectomy) following at least one padeliporfin VTP treatment
Measured: After at least one VTP treatment
Patients with ureteral obstruction and/or ureteral stent
Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted with radiographic evidence of pre-existing obstruction documented, to demonstrate the site and degree of obstruction with retrograde pyelography at baseline (prior to treatment) and will be repeated and recorded at 12 months maintenance treatment visit (post treatment) which will further be supported with CT Urogram results at 12 months to demonstrate the site and degree of obstruction using standard nomenclature.
Measured: Baseline 12 months
Long Term follow-up Duration of the response
The duration of response in the ipsilateral kidney and treatment area will be defined as absence of disease, based on:
- instrumented cytology
- visually on endoscopy
- biopsy pathology (if present and performed)
Measured: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Long Term follow-up Kidney organ loss or preservation
Kidney organ loss or preservation will be recorded and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss and a pathology report of the removed tissue will be recorded (if available or feasible)
Measured: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Long Term follow-up Overall renal functional
Overall renal functional outcome will be evaluated by estimated glomerular filtration rate(eGFR) using CKD-Epimethod
Measured: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Long Term follow-up Safety Follow up
Safety follow up based and recording of adverse events
Measured: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Exploratory Endpoint
Blood,tumor and cytology samples will be collected, centrally stored and later submitted for tumor genomic sequencing studies to explore the tumor genomic alterations, and mutation status as biomarkers with association to treatment response and progression events such as recurrence, grade transformation, increased stage and metastases.
Measured: Baseline
Pharmacokinetic Endpoint Cmax
Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate Cmax
Measured: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint Tmax
Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate Tmax
Measured: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint T1/2
Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate T1/2
Measured: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint AUC
Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate AUC
Measured: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint CL
Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate CL
Measured: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start22 Mar 2021
- Primary completion1 Jul 2026
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Cell Cancer of Renal Pelvis and UreterStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase III, single arm, non randomized, multicenter trial
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- PrimeVigilance, ICON plc
- Responsible party
- Sponsor
- Investigators
- Vitaly Margulis, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620239
- Sponsor's protocol ID
- CLIN2001 UCM301
- Acronym
- UCM301
- Status last verified
- Jul 2026
- First submitted
- 5 Nov 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (Padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer
- ClinicalTrials.gov ID
- NCT04620239
- Acronym / sponsor ID
- UCM301 / CLIN2001 UCM301
- Keywords
- UTUC, Low Grade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Collaborators
- PrimeVigilance, ICON plc
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 Nov 2020 (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.
This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment
Detailed description
Induction Treament Phase: Patients entered in the study will undergo an induction treatment phase consisting of 1-3 padeliporfin VTP treatments provided 4 weeks (28 +/-3 days) apart. The goal of this induction treatment phase will be to achieve Complete Response (CR) in the involved ipsilateral tract system. During this phase, patients will be treated with padeliporfin VTP to visually identified tumor sites in the calyces, renal pelvis and/or ureter and subsequently examined endoscopically at 28 +/- 3 days post treatment to determine whether the treatment was successful. If CR is not achieved, an additional two treatments of padeliporfin VTP are permitted 28 +/- 3 days apart for a total of up to 3 treatments during the induction treatment phase. The Primary Response Evaluation (PRE) will be performed 28 +/- 3 days after the last VTP treatment, to determine if the treatment was successful at achieving CR defined as: absence of visible tumor on endoscopy, negative urinary cytology by instrumented collection, and no evidence of tumor on biopsy (if feasible). Patients undergoing extirpative surgery of any part of the ipsilateral kidney or ureter for indications related to urothelial cancer will be considered as no longer having CR. If CR is not achieved after 3 treatments with padeliporfin VTP the treatment will be considered unsuccessful and the patient will be discontinued from the Treatment Phases.
Maintenance Treatment Phase: Patients achieving CR at the induction treatment phase will be allowed into the maintenance treatment phase of the study. The patients will then be followed over a period of 12 months post PRE, to assess the duration of response and its safety, and to provide planned maintenance treatment.
Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable as defined by the following criteria: low-grade tumors with the largest tumor (index tumor) betwen 5 mm and 15 mm in diameter, in up to 2 anatomical locations in the calyces, renal pelvis or the ureter with ureter involvement in one anatomical location with no more than 20 mm of contiguous ureteral length). Patients with treatable tumor recurrence post Induction Treatment Phase would be considered as no longer having 'complete response in the entire ipsilateral kidney' and time to recurrence will be recorded. Patients undergoing extirpative surgery of any part of the ipsilateral kidney or ureter for indications related to urothelial cancer will be considered as no longer having CR and time to this event will be recorded.
Long Term Follow-up Phase: Patients completing the 12 months of the maintenance treatment phase of the study, could be followed for an additional 48 months to monitor for disease related outcomes and VTP treatment related adverse events with the specific duration depending on the patient's response to treatment. No additional padeliporfin VTP treatment will be administered during this phase. Patients completing the maintenance phase of the study who are in CR in V3 will undergo additional assessments 18 and 24 months (+/- 1 month) post-PRE and annually thereafter and for up to 5 years post PRE or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase III, single arm, non randomized, multicenter trial
| Arm | Type | Receives |
|---|---|---|
| padeliporfin VTP | Experimental | Drug: padeliporfin VTPInduction Treatment phase:1-3 padeliporfin VTP treatments provided 4 weeks (28 +/-3 days) apart. Maintenance Treatment Phase: Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female patients 18 years or older
- Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
- New or recurrent low-grade, non-invasive UTUC disease
- Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility.
- Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces,renal pelvis or in the ureter of the ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length)
Key exclusion criteria (11 listed)
- Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
- Carcinoma in situ (CIS) current or previous in the upper urinary tract
- History of invasive T2 or higher urothelial cancer in past 2 years
- Participation in another clinical study involving an investigational product within 1 month before study entry
- BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
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 |
|---|---|---|
| padeliporfin VTPAlso: WST11During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes. | Drug | padeliporfin VTP |
Primary outcome
Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter
Time frame: 28 +/- 3 days post last treatment
Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response. · Complete Response will be defined as absence of disease based on: * absence of visual tumor on endoscopy * no evidence of tumor on biopsy (if feasible) * negative urinary cytology by instrumented collection
17 secondary outcomes
Duration of response at the entire ipsilateral kidney
Time frame: 12 months post PRE
Duration of response at the entire ipsilateral kidney
Time frame: 3, 6, 9 months post PRE
Duration of response at the Treatment Area of the ipsilateral kidney
Time frame: 3, 6, 9, and 12 months post PRE
Overall renal function
Time frame: 6 and 12 months post PRE
Kidney organ loss or preservation
Time frame: 3, 6, 9, and 12 months post PRE
Pathological evaluation of response
Time frame: After at least one VTP treatment
Patients with ureteral obstruction and/or ureteral stent
Time frame: Baseline 12 months
Long Term follow-up Duration of the response
Time frame: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Long Term follow-up Kidney organ loss or preservation
Time frame: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Long Term follow-up Overall renal functional
Time frame: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Long Term follow-up Safety Follow up
Time frame: 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE
Exploratory Endpoint
Time frame: Baseline
Pharmacokinetic Endpoint Cmax
Time frame: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint Tmax
Time frame: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint T1/2
Time frame: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint AUC
Time frame: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
Pharmacokinetic Endpoint CL
Time frame: 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection
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 30 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vitaly Margulis, MD principal investigator
University of Texas Southwestern Medical Center
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing padeliporfin VTP in people with Transitional Cell Cancer of Renal Pelvis and Ureter, run by Steba Biotech S.A. at 18 sites in 5 countries.
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 12 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, France, Spain, Germany, Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter (time frame: 28 +/- 3 days post last treatment). 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 30 Jul 2026.