BridgeMD
This is a study that will evaluate the safety and efficacy of TOOKAD® (padeliporfin) Vascular Targeted Photodynamic Therapy (VTP) in the Treatment of Low-Grade Upper Tract Urothelial Cancer (UTUC).
EU CTIS ID: 2024-512322-28-00
What this study is testing
To demonstrate the efficacy and durability of effect following TOOKAD (padeliporfin) VTP on low grade UTUC tumors in the calyces, renal pelvis and ureter
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 the ureter of 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%
You likely can't join if
- Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
- 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 TOOKAD VTP treatment
- 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
See the full eligibility criteria
- 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 the ureter of 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%
- Adequate organ function defined at baseline as: ▪ANC ≥1,000/ μl, ▪Platelets ≥75,000/ μl, Hb ≥9 g/dl, ▪INR ≤2, ▪Estimated glomerular filtration rate eGFR ≥30 ml/min using CKD-EPI Method, ▪Total serum bilirubin <3 mg/dL, AST/ALT ≤5× upper limit of normal
- Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
- 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 TOOKAD VTP treatment
- 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
- 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, 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
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.