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NCT07332351 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial
A Phase 2 study, sponsored by University of Washington.
- Not yet
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT07332351 is a Phase 2 study that has not yet begun recruiting, run by University of Washington. The registered enrollment target is 33 participants.
The verdict
NCT07332351, a Phase 2 study, has not yet begun recruiting, sponsored by University of Washington.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with gemcitabine, cisplatin and durvalumab before (neoadjuvant) radical cystectomy (RC) in treating patients with muscle invasive bladder cancer. The combination of gemcitabine, cisplatin and durvalumab are already considered standard of care in the treatment of muscle invasive bladder cancer. This trial attempts to determine whether the addition of nadofaragene firadenovec to the current standard regiment is safe and can improve oncological outcomes for those with muscle invasive bladder cancer. Nadofaragene firadenovec, a type of intravesical gene therapy, is a weakened adenovirus that carries a copy of the gene for interferon alfa-2b. This medication gets absorbed by the bladder and stimulates the bladder to naturally create interferon alfa-2b, which is thought to kill bladder cancer. Nadofaragene firadenovec is given in a solution that is placed directly into the bladder (intravesical) using a thin tube called a catheter. It is a medication that is already FDA approved for the treatment of non-muscle invasive bladder cancer. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.
Interventions
- DRUG Cisplatin
- BIOLOGICAL Durvalumab
- DRUG Gemcitabine
- PROCEDURE Radical Cystectomy
- BIOLOGICAL Nadofaragene Firadenovec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07332351
The ClinicalTrials.gov registry entry for NCT07332351 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT07332351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07332351 about?
NCT07332351 is a clinical study titled "Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial". This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with gemcitabine, cisplatin and durvalumab before (neoadjuvant) radical cystectomy (RC) in treating patients with muscle invasive bladder cancer. The combination of gemcitabine, cisplatin and durvalumab are ...
What is the current status of trial NCT07332351?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2026-09-01. Estimated completion is 2027-02-01.
What interventions are being tested in trial NCT07332351?
The interventions under investigation include: Cisplatin (DRUG), Durvalumab (BIOLOGICAL), Gemcitabine (DRUG), Radical Cystectomy (PROCEDURE), Nadofaragene Firadenovec (BIOLOGICAL).
Who is sponsoring clinical trial NCT07332351?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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