Kidney Cancer Clinical Trial

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion 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 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%

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

Exclusion Criteria:

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

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT04620239

Recruitment Status:

Recruiting

Sponsor:

Steba Biotech S.A.

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There are 27 Locations for this study

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University of California - Irvine Medical Center
Irvine California, 92868, United States More Info
Edward Uchio, MD
Contact
Keck School of Medicine at USC Medical Center
Los Angeles California, 90033, United States More Info
Hooman Djaladat, MD
Contact
Emory University Hospital
Atlanta Georgia, 30322, United States More Info
Kenneth Ogan, MD
Contact
The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States More Info
Nirmish Singla, MD
Contact
Albany Medical College
Albany New York, 12208, United States More Info
Prof. Ronald Kaufman, MD
Contact
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Jonathan Coleman, MD
Contact
Eugene Pietzak,, MD
Contact
The Ohio State University (OSU)
Columbus Ohio, 43210, United States More Info
Ahmad Shabsigh, MD
Contact
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States More Info
Jay Raman, MD
Contact
Medical University of South Carolina (MUSC)
Charleston South Carolina, 29425, United States More Info
Robert Grubb, MD
Contact
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Neal Shore, MD
Contact
University of Texas Southwestern
Dallas Texas, 75390, United States More Info
Vitaly Margulis, MD
Contact
University of Washington
Seattle Washington, 98195, United States More Info
Sarah Psutka, MD
Contact
Urologie und Andrologie Ordensklinikum Linz GmbH Elisabethinen
Linz , 4020, Austria More Info
Reinhard Aigner, MD
Contact
CHU de Lille - Hopital Claude Huriez
Lille , 59037, France More Info
Gautier Marcq, MD
Contact
HCL Hopital Edouard Herriot
Lyon , 69437, France More Info
Prof. Marc Colombel, MD, PhD
Contact
Institut Paoli-Calmettes
Marseille , 13009, France More Info
Jochen Walz, MD
Contact
CHU de Rouen - Hopital Charles-Nicolle
Rouen , 76000, France More Info
Christian Pfister, MD
Contact
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden , 01307, Germany More Info
Prof. Christian Thomas, MD
Contact
Universitaetsklinikum Tuebingen
Tübingen , 72076, Germany More Info
Steffen Rausch, MD
Contact
Rambam Health Care Campus
Haifa , 31096, Israel More Info
Michael Mullerad, MD
Contact
Sheba Medical Center
Ramat Gan , , Israel More Info
Asaf Shvero, MD
Contact
Kaplan Medical Center
Rehovot , 76100, Israel More Info
Prof. Dan Leibovici, MD
Contact
Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy More Info
Prof. Mauro Gacci, MD
Contact
Policlinico Universitario Campus Bio-Medico
Roma , 00128, Italy More Info
Prof. Roberto Mario Scarpa, MD
Contact
AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
Torino , 10126, Italy More Info
Francesco Soria, MD
Contact
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain More Info
Carles Xavier Raventós Busquets, MD
Contact
Hospital Universitario de A Coruña
Coruña , 15006, Spain More Info
Marco Aller, MD
Contact
Hospital Universitario Reina Sofía
Córdoba , 14004, Spain More Info
Francisco Jose Anglada Curado, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT04620239

Recruitment Status:

Recruiting

Sponsor:


Steba Biotech S.A.

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