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Brief Title: ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) 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
Study ID: NCT04620239
Brief 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. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California - Irvine Medical Center, Irvine, California, United States
Keck School of Medicine at USC Medical Center, Los Angeles, California, United States
Emory University Hospital, Atlanta, Georgia, United States
The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Albany Medical College, Albany, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
The Ohio State University (OSU), Columbus, Ohio, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Medical University of South Carolina (MUSC), Charleston, South Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
University of Texas Southwestern, Dallas, Texas, United States
University of Washington, Seattle, Washington, United States
Urologie und Andrologie Ordensklinikum Linz GmbH Elisabethinen, Linz, , Austria
CHU de Lille - Hopital Claude Huriez, Lille, , France
HCL Hopital Edouard Herriot, Lyon, , France
Institut Paoli-Calmettes, Marseille, , France
CHU de Rouen - Hopital Charles-Nicolle, Rouen, , France
Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitaetsklinikum Tuebingen, Tübingen, , Germany
Rambam Health Care Campus, Haifa, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Kaplan Medical Center, Rehovot, , Israel
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Policlinico Universitario Campus Bio-Medico, Roma, , Italy
AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette, Torino, , Italy
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario de A Coruña, Coruña, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Name: Inna Krasnopolskaya
Affiliation: Steba biotech
Role: STUDY_CHAIR