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

Launched by STEBA BIOTECH S.A. · Nov 5, 2020

Keywords

ClinConnect Summary

The ENLIGHTED study is a clinical trial that is testing a new treatment called padeliporfin for patients with a type of cancer known as upper tract urothelial carcinoma (UTUC). This cancer can occur in the kidney or ureter and is considered low-grade and non-invasive, meaning it hasn’t spread deeply into the tissues. The trial is open to adults aged 18 and older who have been diagnosed with this specific type of cancer and meet certain health criteria. For example, eligible participants should have a small tumor size that falls within specific measurements and must be able to provide informed consent for the study.

Participants in this trial will receive the padeliporfin treatment in two phases: an initial treatment phase followed by a maintenance phase. Throughout the study, they will be monitored for up to four years to see how well the treatment works and to assess their health over time. It's important to note that individuals with certain types of more aggressive cancer, recent treatments, or specific health issues may not qualify for this trial. Overall, the ENLIGHTED study aims to find out if this new treatment can help manage low-grade UTUC effectively.

Gender

ALL

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.