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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: Clinical Trial Phase 2 study, sponsored by University of Washington.
NCT07332351 is a Phase 2 study that has not yet begun recruiting, run by University of Washington. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be defined as the proportion of participants achieving ypT0N0. Will employ Simon's optimal two-stage design (Simon, 1989) to test the null hypothesis that the true pCR rate is 33.8% versus the alternative hypothesis of 56%. The observed pCR rate will be reported with an exact 95% confidence interval using the Clopper-Pearson method.
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 |
What is known before NCT07332351 opens enrollment
NCT07332351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT07332351 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07332351's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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