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TRIFECTA Trial: Adding Nadofaragene Firadenovec to Standard Treatment for Muscle-Invasive Bladder Cancer

This study is looking at a new way to treat muscle-invasive bladder cancer. It combines standard treatments (gemcitabine, cisplatin, and durvalumab) with a new treatment called nadofaragene firadenovec before surgery (radical cystectomy). Nadofaragene firadenovec is a gene therapy given directly into the bladder. The study wants to see if adding nadofaragene firadenovec is safe and can improve how well the treatment works for patients with bladder cancer that has grown into the muscle. You may be able to join if you are at least 18 years old and have muscle-invasive bladder cancer that you plan to have surgically removed. The study will measure success by looking at how much the cancer shrinks or disappears by the time of surgery. This study plans to enroll 33 participants, but its current recruitment status is unclear.

Study design
This is a phase II interventional study. It plans to enroll 33 participants.
What's involved
You would receive intravenous (IV) durvalumab, gemcitabine, and cisplatin, plus nadofaragene firadenovec directly into your bladder. These treatments repeat every 21 days for up to 4 cycles, followed by surgery. You will also have urine and blood tests, and imaging scans like CT, MRI, or PET/CT.
Compensation
Not stated in the trial record.
Follow-up
After surgery, you will be followed for up to 30 days to check for any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07332351

Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~33 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:Nadofaragene FiradenovecDurvalumabGemcitabineCisplatinRadical CystectomyBiospecimen Collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathological complete response (pCR) on radical cystectomy (RC) specimen
Measured over At time of radical cystectomy (RC), approximately 4-8 weeks following completion of neoadjuvant systemic therapies
+1 more outcome measured

Conditions

Muscle Invasive Bladder Urothelial Carcinoma
Stage II Bladder Cancer AJCC v8
Stage IIIA Bladder Cancer AJCC v8

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Bladder Carcinoma

NCT07332351

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washingtonstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jonathan Wright, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Jonathan Wright, MD
[email protected]
206-598-4294
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years at the time of screening
Ability to understand and willingness to sign the written informed consent document
Patients with confirmed muscle-invasive urothelial carcinoma of the bladder (cT2-4a, N0-1, M0 or cT1, N1, M0), who are planning to undergo RC
Pure urothelial or mixed histologic subtypes are allowed if urothelial is the primary histology (regardless of the % of conventional urothelial histology)
Eligible to receive neoadjuvant cisplatin/gemcitabine and durvalumab per the patient's medical oncologist's discretion
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Hemoglobin count ≥ 9 gm/dL
Absolute neutrophil count of ≥ 1500 cells/uL
Platelet count of ≥ 100,000/uL
Alanine and aspartate aminotransferase levels ≤ 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN for Gilbert syndrome)
Creatinine clearance or estimated glomerular filtration rate (GFR) ≥ 40ml/min (using Chronic Kidney Disease Epidemiology Collaboration Formula \[CKD-EPI\] 2021 equation)
For patients with evidence of, or history of HIV, chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the viral load must be undetectable, or the infection must have been treated and cured. Patients are not allowed to be on immunosuppressive agents for HIV, HBV or HCV. Routine testing for HIV, HBV and HCV is not required for patients without such history unless clinically indicated
Individuals with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are allowed to enroll

Exclusion

cT4b, N2-3, or M1 stage at time of screening
Any known concurrent clinically relevant malignancies
Prior systemic therapy for muscle-invasive bladder carcinoma (MIBC) (prior intravenous pembrolizumab for non-muscle invasive bladder carcinoma \[NMIBC\] is allowed)
Current or prior use of systemic immunosuppressive medication within 14 days before first dose of investigational product. The following are allowed (not systemic route): intranasal, inhaled, intra-articular, topical steroids, local steroid injections
Pure non-urothelial histology subtype/variant or any neuroendocrine (small or large cell) component
Prior treatment with adenovirus-based drugs
Known hypersensitivity or allergy to any components of rAd-interferon (IFN)a/Syn3
Currently receiving other investigational agent
Pregnant or lactating women

What this trial measures

  • Pathological complete response (pCR) on radical cystectomy (RC) specimenAt time of radical cystectomy (RC), approximately 4-8 weeks following completion of neoadjuvant systemic therapies

    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.

  • Downstaging (≤ ypT1N0) on RC specimenAt time of radical cystectomy (RC), approximately 4-8 weeks following completion of neoadjuvant systemic therapies