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

Sponsor:

Steba Biotech S.A.

Sponsor Study ID:

CLIN2001 UCM301

CTO #:

103416

NCT Number:

NCT04620239

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Bladder

Study Objectives:

This is a phase 3, open label, single arm study of TOOKAD in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade upper tract urothelial carcinoma in either the kidney or the ureter. The patients will be treated with TOOKAD (padeliporfin) VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase.

eConsent:

Not available

Study Documents:

Open Study Documents
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