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Photosensitizer

Padeliporfin VTP for Bladder Cancer (UCM301 Trial)

Phase 3

Recruiting

Led By Vitaly Margulis, MD

Research Sponsored by Steba Biotech S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Estimated glomerular filtration rate (eGFR) ≥30 ml/min (using CKD-EPI Method)

Karnofsky Performance Status ≥ 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18, 24,36,48 and 60 months post pre or 6 and 12 months post pre

Awards & highlights

UCM301 Trial Summary

This trial is testing a new cancer treatment called padeliporfin. Patients with a certain type of bladder cancer will be treated with padeliporfin and followed for up to 4 years to see how well it works.

Who is the study for?

The ENLIGHTED study is for adults with low-grade, non-invasive cancer in the kidney or ureter. Participants should have good physical function, specific tumor sizes and locations, normal blood counts and organ functions. Excluded are those with invasive cancers within 2 years, recent BCG/chemotherapy treatments, severe other diseases or heavy smoking habits, current high-grade bladder cancer or CIS in the upper tract.Check my eligibility

What is being tested?

This phase 3 trial tests padeliporfin VTP on patients with Upper Tract Urothelial Carcinoma (UTUC). It involves an Induction Treatment Phase followed by a Maintenance Treatment Phase. Patients will be monitored up to four additional years post-treatment to assess long-term effects of this single-arm intervention.See study design

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions to photodynamic therapy like tissue inflammation at treatment sites, photosensitivity reactions due to light activation of padeliporfin VTP and general discomfort associated with endoscopic procedures.

UCM301 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by eGFR, is at least 30 ml/min.

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I can do most of my daily activities by myself.

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I have up to 2 low-grade tumors in my kidney or ureter, with the largest being 5-15 mm.

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My cancer is a low-grade, non-invasive type in the upper urinary tract.

UCM301 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18, 24,36,48 and 60 months post pre or 6 and 12 months post pre

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18, 24,36,48 and 60 months post pre or 6 and 12 months post pre

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18, 24,36,48 and 60 months post pre or 6 and 12 months post pre for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter

Secondary outcome measures

Duration of response at the Treatment Area of the ipsilateral kidney

Duration of response at the entire ipsilateral kidney

Exploratory Endpoint

+13 more

UCM301 Trial Design

1Treatment groups

Experimental Treatment

Group I: padeliporfin VTPExperimental Treatment1 Intervention

Induction Treatment phase:1-3 padeliporfin VTP treatments provided 4 weeks (28 +/-3 days) apart. Maintenance Treatment Phase: Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ICON plcIndustry Sponsor

80 Previous Clinical Trials

25,004 Total Patients Enrolled

Medpace, Inc.Industry Sponsor

94 Previous Clinical Trials

29,515 Total Patients Enrolled

PrimeVigilanceIndustry Sponsor

5 Previous Clinical Trials

190 Total Patients Enrolled

Media Library

Padeliporfin VTP (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT04620239 — Phase 3

Transitional Cell Carcinoma Research Study Groups: padeliporfin VTP

Transitional Cell Carcinoma Clinical Trial 2023: Padeliporfin VTP Highlights & Side Effects. Trial Name: NCT04620239 — Phase 3

Padeliporfin VTP (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04620239 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do we have an opportunity to participate in this ongoing research?

"Yes, the latest information on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was originally posted on 3/22/2021 and was updated on 2/7/2022. They are looking for 100 people to participate at 3 different locations."

Answered by AI

Padeliporfin VTP is mostly used for what purpose?

"Padeliporfin VTP is an effective treatment for photochemotherapy, malignant neoplasm of prostate, and other forms of cancer that have not yet been treated."

Answered by AI

Has the FDA greenlit padeliporfin VTP for general use?

"Padeliporfin VTP has undergone Phase 3 trials, meaning that there is both supportive efficacy data as well as multiple rounds of safety data. Consequently, our team rates its safety as a 3."

Answered by AI

Could you please list any other research that has been done on padeliporfin VTP?

"There are 2 clinical trials currently underway that are researching padeliporfin VTP. Out of these, 1 is in Phase 3. Additionally, although many of the trials are based in New york City, there are a total of 5 locations running these sorts of studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04620239.