A Phase 2 interventional study of Nadofaragene Firadenovec and Enfortumab Vedotin in Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8, sponsored by University of Washington. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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Among 24 studies testing enfortumab vedotin in Urinary Bladder Neoplasms — 15 open to participants now, 19 under way, 5 of them phase 3. enfortumab vedotin · Urinary Bladder Neoplasms.
Among the 24 studies testing enfortumab vedotin in Urinary Bladder Neoplasms, this one is the 20th largest by planned enrollment, is one of 8 that started in 2026, is one of 9 in phase 2, reaches primary completion later than 7 of the 18 other live ones, and was the 19th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →15 of the 24 studies testing enfortumab vedotin in Urinary Bladder Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Fox Chase Cancer Center · Sites in United States
Ages 18+
Astellas Pharma Global Development, Inc. · Sites in United States, Canada, Korea, Republic of and 1 more country
Ages 18+
Astellas Pharma Global Development, Inc. · Sites in United States, Australia, Canada and 9 more countries
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
By country, each count listing its studies:
enfortumab vedotin: first FDA approval 2019 (PADCEV), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, enfortumab vedotin is the treatment under test here. Read study by study →
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 15 · Phase 3 6
First in 2017; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 63 across the 24 interventional studies. Of the 5 that completed or were terminated, 3 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 24 have an industry lead sponsor. The 10 most frequent:
University of Washington is the lead sponsor of 1,434 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
12 studies in Urinary Bladder Neoplasms by University of Washington: 6 open now, 7 under way, none of them phase 3. Of 5 finished, 5 (100%) have results posted.
Among the 12 studies in Urinary Bladder Neoplasms by University of Washington, this one is one of 3 that started in 2026, is one of 3 in phase 2, and was the 11th registered.
University of Washington’s Urinary Bladder Neoplasms studies by the year they started, since 2009.
6 of the studies testing enfortumab vedotin in Urinary Bladder Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04963153National Cancer Institute (NCI)Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy | 2026-12-01 |
| NCT05756569Emory UniversityEnfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology | 2026-12-16 |
| NCT04724018Dana-Farber Cancer InstituteSacituzumab Govitecan Plus EV in Metastatic UC | 2027-02-01 |
| NCT07332351University of WashingtonNeoadjuvant Intravesical Nadofaragene Firadenovec With Enfortumab Vedotin and Pembrolizumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial | 2027-06-01 |
| NCT06434350M.D. Anderson Cancer CenterEnfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) | 2027-09-24 |
Add all 6 to your calendar (.ics) → With an account.
Among the 24 studies testing enfortumab vedotin in Urinary Bladder Neoplasms, from their registry updates:
Among University of Washington’s 12 in Urinary Bladder Neoplasms:
This tab as a report to print or save as PDF → With an account.
This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with enfortumab vedotin and pembrolizumab before (neoadjuvant) radical cystectomy in treating patients with muscle invasive bladder cancer. The combination of enfortumab vedotin and pembrolizumab 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 Food and Drug Administration approved for the treatment of non-muscle invasive bladder cancer.
Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate.
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.
Investigators aim to assess whether adding intravesical nadofaragene firadenovec to the current recommended treatment of enfortumab vedotin and pembrolizumab before undergoing a radical cystectomy may be safe, tolerable, and/or effective in treating patients with muscle-invasive bladder cancer.
OUTLINE:
Patients receive standard of care neoadjuvant therapies for muscle invasive bladder cancer including: enfortumab vedotin intravenously (IV) on days 1 and 8 and pembrolizumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity. In addition, patients will also receive nadofaragene firadenovec intravesically on day 1 of cycle 1 (one total dose during the entire neoadjuvant period). Starting 4-8 weeks after completion of treatment, patients undergo radical cystectomy (RC) per standard clinical care. Additionally, patients undergo urine and blood sample collection and computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT throughout the study.
After completion of study treatment, patients are followed for up to 30 days post-cystectomy to monitor for adverse events.
The criteria were revised on the registry on Nov 13, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive standard of care neoadjuvant therapies for muscle invasive bladder cancer including: enfortumab vedotin IV on days 1 and 8 and pembrolizumab IV on day 1 of each cycle. In addition, patients also receive nadofaragene firadenovec intravesically on day 1 of cycle 1 (total of 1 dose in neoadjuvant period). 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. Additionally, patients undergo urine and blood sample collection and CT, MRI or PET/CT throughout the study.
Biological: Nadofaragene Firadenovec · Drug: Enfortumab Vedotin · Biological: Pembrolizumab · Procedure: Radical Cystectomy · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Procedure: Magnetic Resonance Imaging
Given intravesically
Also known as: Adstiladrin, Instiladrin, Recombinant Adenovirus-Interferon SCH 721015, Recombinant Adenovirus-Interferon With Syn3, Recombinant Adenovirus-Interferon/Syn3, SCH 721015
Given IV
Also known as: Padcev, AGS-22M6E, Anti-Nectin 4 ADC ASG-22CE, Anti-nectin-4 Monoclonal Antibody-Drug Conjugate AGS-22M6E, ASG 22CE
Given IV
Also known as: Keytruda
Undergo RC
Also known as: RC
Undergo urine and blood sample collection
Also known as: Biological Sample Collection
Undergo CT or PET/CT
Also known as: CT, CT Scan, CAT Scan
Undergo PET/CT
Also known as: PET, PET Scan
Undergo MRI
Also known as: MRI
Proportion of patients who receive nadofaragene firadenovec and complete at least 2 cycles of enfortumab vedotin and pembrolizumab in the neoadjuvant period followed by radical cystectomy
Will be calculated as the number of patients who complete the planned course divided by the total number of enrolled patients who initiate therapy. Exact 95% confidence intervals will be reported. Reasons for non-completion will be summarized descriptively.
Time frame: Within 10 weeks from last neoadjuvant therapy dose
Incidence of grade 3 or higher treatment-related adverse events (AE)
Will be graded by provider-scored toxicity via the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Will be summarized descriptively, including the number and proportion of patients experiencing at least one grade ≥ 3 AE, and the type, severity, and relatedness of all treatment-related AEs, attributed by agent.
Time frame: From initiation of neoadjuvant systemic therapies (day 1 of cycle 1; 4 cycles total; each cycle is 21 days), through 30 days post-RC (RC occurs approximately 4-8 weeks after completion of neoadjuvant systemic therapies)
Incidence of AEs
Will be summarized by maximum CTCAE grade and relatedness to the treatment.
Time frame: From initiation of neoadjuvant systemic therapies (day 1 of cycle 1; 4 cycles total; each cycle is 21 days), through 30 days post-RC (RC occurs approximately 4-8 weeks after completion of neoadjuvant systemic therapies)
Pathologic complete response (pCR) on radical cystectomy (RC) specimen
Will be defined as the proportion of participants achieving ypT0N0. Will assume the null hypothesis that the true pCR rate is 56 % with the alternative hypothesis of 65%. The observed pCR rate will be reported with an exact 95% confidence interval using the Clopper-Pearson method.
Time frame: At time of radical cystectomy (RC), approximately 4-8 weeks following completion of neoadjuvant systemic therapies
Downstaging (≤ ypT1N0) on RC specimen
Time frame: At time of RC, approximately 4-8 weeks following completion of neoadjuvant systemic therapies
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.
Of 155 non-industry phase 2 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 103. This study's planned 6 months is below that.
Counting every sponsor, half of 194 studies reached it within 52 months; a quarter within 36 and three quarters within 91.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 13, 2026: primary completion Jan 2027 → Jun 2027 and completion Feb 2027 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Nadofaragene firadenovec · Enfortumab vedotin · Pembrolizumab