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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
Eligibility Criteria
Inclusion Criteria
- 1Male and female patients 18 years or older
- 2Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
- 3New or recurrent low-grade, non-invasive UTUC disease
- 4Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility.
- 5Up 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)
- 6Karnofsky Performance Status ≥ 50%
- 7Adequate organ function defined at baseline as:
- 8ANC ≥1,000/ μl,
- 9Platelets ≥75,000/ μl, Hb ≥9 g/dl,
- 10INR ≤ 2
- 11Estimated glomerular giltration rate (eGFR) ≥30 ml/min (using CKD-EPI Method)
- 12Total serum bilirubin \<3 mg/dL, AST/ALT ≤5× upper limit of normal
Exclusion Criteria
- 1Current high-grade or muscle invasive (\>pT1) urothelial carcinoma of the bladder
- 2Carcinoma in situ (CIS) current or previous in the upper urinary tract
- 3History of invasive T2 or higher urothelial cancer in past 2 years
- 4Participation in another clinical study involving an investigational product within 1 month before study entry
- 5BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
- 6Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment
- 7Prohibited medication that could not be adjusted or discontinued prior to study treatment
- 8Patients with photosensitive skin diseases or porphyria
- 9Any 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
- 10Pregnant or breast-feeding women.Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry.
- 11Men 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.
Locations
22 sites participating in this study
Emory University Hospital
Atlanta, Georgia 30322
Kenneth Ogan, MD
University of California - Irvine Medical Center
Irvine, California 92868
Edward Uchio, MD
Keck School of Medicine at USC Medical Center
Los Angeles, California 90033
Hooman Djaladat, MD