Nadofaragene Firadenovec + Standard Therapy for Bladder Cancer
(TRIFECTA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for people with muscle-invasive bladder cancer. Researchers aim to determine if adding the gene therapy nadofaragene firadenovec to standard chemotherapy and immunotherapy improves outcomes. The goal is to assess the safety and effectiveness of this combination before bladder removal surgery. Individuals with muscle-invasive bladder cancer scheduled for surgery might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nadofaragene firadenovec is generally safe. Studies on patients with non-muscle invasive bladder cancer found it well-tolerated, with many patients experiencing no serious side effects. The FDA has already approved this treatment for this type of bladder cancer, indicating its general safety.
The other treatments in this trial—gemcitabine, cisplatin, and durvalumab—are commonly used for bladder cancer and have established safety records. Combining these with nadofaragene firadenovec aims to improve results while maintaining safety.12345Why are researchers excited about this study treatment for bladder cancer?
Nadofaragene firadenovec is unique because it uses a novel gene therapy approach to treat bladder cancer. Unlike traditional treatments like surgery, chemotherapy, and immunotherapy, this treatment delivers a virus directly into the bladder, introducing a gene that helps the body's own immune system to fight cancer cells. Researchers are excited because this method has the potential to enhance the body's natural defenses specifically within the bladder, offering a targeted approach that could lead to fewer side effects and improved effectiveness compared to current options.
What evidence suggests that nadofaragene firadenovec combined with standard therapy could be effective for muscle invasive bladder cancer?
Research has shown that nadofaragene firadenovec effectively treats non-muscle invasive bladder cancer. In earlier studies, nearly half of the patients who received this treatment retained their bladder for up to 60 months. This treatment uses a virus to deliver a gene that produces interferon alfa-2b, a substance that helps destroy cancer cells. The therapy is administered directly into the bladder, targeting the cancer's location. In this trial, researchers are testing nadofaragene firadenovec alongside standard treatments, including durvalumab, gemcitabine, and cisplatin, to evaluate its potential benefits for those with muscle invasive bladder cancer.13467
Who Is on the Research Team?
Jonathan Wright, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for patients with muscle invasive bladder cancer who are candidates for radical cystectomy. It's testing if adding nadofaragene firadenovec to the standard chemo and immunotherapy regimen before surgery can improve outcomes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive durvalumab, gemcitabine, cisplatin, and nadofaragene firadenovec. Cycles repeat every 21 days for up to 4 cycles.
Radical Cystectomy (RC)
Participants undergo radical cystectomy 4-8 weeks after completion of neoadjuvant therapies.
Follow-up
Participants are monitored for adverse events and effectiveness for up to 30 days post-cystectomy.
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Durvalumab
- Gemcitabine
- Nadofaragene Firadenovec
Trial Overview
The TRIFECTA trial is examining the safety and effectiveness of combining gene therapy (nadofaragene firadenovec) with chemotherapy drugs (gemcitabine, cisplatin) and an immunotherapy drug (durvalumab), compared to the current standard care before surgical removal of the bladder.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive durvalumab IV over 60 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV on day 1 or days 1 and 8 of each cycle. Patients also receive nadofaragene firadenovec intravesically on day 1 of cycles 1 and 4. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Starting 4-8 weeks after treatment, patients undergo RC per standard clinical care. Following RC, patients may receive durvalumab at the discretion of the clinician. Additionally, patients undergo urine and blood sample collection and CT, MRI or PET/CT throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Ferring Pharmaceuticals
Industry Sponsor
Pierre-Yves Berclaz
Ferring Pharmaceuticals
Chief Medical Officer since 2023
MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine
Jean-Frédéric Paulsen
Ferring Pharmaceuticals
Chief Executive Officer since 2023
Master’s degree in Finance from the London School of Economics and Political Science
Citations
Real-world outcomes of nadofaragene firadenovec for BCG ...
With median follow-up of 13.9 months, cystectomy-free and overall survival were 93% and 95%, respectively. Progression occurred in 5 patients.
Real-world outcomes of nadofaragene firadenovec in BCG ...
Early real-world data demonstrates encouraging clinical complete response rates in patients with BCG-unresponsive NMIBC and a favorable safety profile.
ASCO GU 2025: Real-World Outcomes of Nadofaragene ...
This study analyzed patients treated with nadofaragene firadenovec for BCG-unresponsive non-muscle invasive bladder cancer across three Mayo Clinic sites.
The effectiveness and value of nadofaragene firadenovec, ...
In the pivotal trial of oportuzumab monatox, 36 (40%) of 89 patients with CIS ± Ta/T1 disease achieved a CR at 3 months, declining to 17% at 12 months. For ...
FINAL RESULTS FROM A PHASE 3 TRIAL
Nadofaragene firadenovec provided nearly half of participants with bladder preservation at 60 months and represents a safe intravesical treatment option.
Bladder Cancer Real-world outcomes of nadofaragene ...
Conclusions. Our multicenter data support the effectiveness and safety of nadofaragene firadenovec in patients with BCG-unresponsive NMIBC. ...
Results from a phase III trial.
Background: Patients (pts) with BCG-unresponsive NMIBC are at significant risk for disease recurrence and progression. While cystectomy can be curative, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.