Muscle Invasive Bladder Urothelial CarcinomaPhase 2NCT06809140
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
A Phase 2 study testing Enfortumab vedotin and Pembrolizumab in people with Muscle Invasive Bladder Urothelial Carcinoma, run by Matthew Galsky at 5 sites in United States.
Trial summary
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Urothelial Carcinoma
- What is being tested?
- Enfortumab vedotin and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Apr 2025to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder clinical stage T2-3N0M0. Participants with mixed histology are eligible provided the urothelial component is ≥50% with the following exceptions: (a) tumors with any degree of squamous differentiation are eligible provided there is a urothelial cancer component, (b) tumors that contain any component of neuroendocrine histology are not eligible. N0 will be considered as the absence of radiographically enlarged lymph nodes on baseline imaging (i.e., Patients with lymph nodes ≥1.5 cm in short axis on imaging are not eligible).
- Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 90 days prior C1D1. A maximal TURBT should be performed when feasible and is defined as a macroscopically complete resection of bladder tumor.
- All subjects must have adequate transurethral resection of bladder tumor tissue available for submission identified during screening. The specimen must include tumor tissue (i.e., if a restaging maximal TURBT was performed and there was no cancer in the specimen, tissue from the most recent prior TURBT that established the diagnosis of muscle-invasive urothelial cancer of the bladder should be submitted). Tissue from both the restaging TURBT and the prior diagnostic TURBT may be requested. Subjects without available archival tissue must be discussed with the sponsor-investigator.
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- Be deemed eligible to undergo radical cystectomy and pelvic lymph node dissection
- Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
- Absolute neutrophil count (ANC): ≥ 1.5 x 10^9/L
- Hemoglobin (Hgb): ≥ 9 g/dL
- Platelets: ≥ 100 x 10^9/L
- Creatinine clearance: ≥ 30 mL/min
- Bilirubin: ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN
- Aspartate aminotransferase (AST): ≤ 2.5 × ULN
- Alanine aminotransferase (ALT): ≤ 2.5 × ULN
- International normalized ratio (INR) or Prothrombin time (PT) or Partial thromboplastin time (PTT): ≤ 1.5 ×ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range for intended use of anticoagulants
- 10. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. WOCBP must agree to use contraception.
- 11. Male participants able to father a child who are sexually active with female of childbearing potential must be willing to use an effective method(s) of contraception.
Who cannot join
- Pre-existing sensory or motor neuropathy Grade ≥ 2
- Ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured. Patients with intermediate or lower risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN) risk stratification guidelines may be eligible for enrollment.
- Prior radiation therapy for bladder cancer.
- Hemoglobin A1c ≥ 8% or hemoglobin A1c 7%-<8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained
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- Active infection requiring systemic therapy.
- Known active Hepatitis B or C infection. NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load are eligible.
- Has a known history of active TB (Bacillus Tuberculosis).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab or enfortumab vedotin and/or any of their excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has had an allogenic tissue/solid organ transplant.
- Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Abhishek Tripathi, MD, 626-218-9200, atripathi@coh.org
Abhishek Tripathi, MD
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Jessica Corman, CCRP, 317-278-5646, jnorflee@iu.edu
Tareq Salous, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lindsay Diamond, 347-514-1561, lindsay.diamond@mssm.edu
Matthew Galsky, MD
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Denisse Mirauti, 212-304-5485, dt2684@cumc.columbia.edu
Alexander Wei, MD
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Alexa Gerchman, alexa.gerchman@fccc.edu
Elizabeth Plimack, MD
About this study
Official title: Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., >cTa disease) will undergo cystectomy.
- Being tested
- Enfortumab vedotin, Pembrolizumab
- Keywords
- MIBC, Pembrolizumab, Enfortumab vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfortumab vedotinDrug
1.25 mg/kg (maximum dose 125 mg)
PembrolizumabDrug
200 mg
| Study group | Role | What they receive |
|---|---|---|
| Enfortumab vedotin plus pembrolizumab | Experimental | Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) plus pembrolizumab (200 mg) followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (defined below) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab (200 mg) will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., >cTa disease) will undergo cystectomy. Receives: Drug: Enfortumab vedotin; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate with enfortumab vedotin plus pembrolizumab for MIBC
Clinical complete response rate will be defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab
Measured: 9 weeks
Bladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response
Estimate the 2-year bladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response
Measured: 2 years
Secondary outcomes (11)
Safety of enfortumab vedotin plus pembrolizumab
Safety will be determined according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Measured: 2 years
Positive predictive value (PPV) of cCR Patients
Estimate the positive predictive value (PPV) of cCR for 2-year metastasis-free survival
Measured: 2 years
Local recurrence-free survival
Estimate invasive local recurrence-free survival in patients achieving a clinical complete response and forgoing immediate cystectomy. Local recurrence free survival is defined as the time from initiation of treatment until the development of invasive local recurrences in the intact bladder.
Measured: 4 years
Association between clinical complete response (cCR) and bladder-intact event-free survival
Estimate association between clinical complete response defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab and bladder-intact event-free survival defined from initiation of treatment until radical cystectomy, evidence of unresectable or metastatic disease, or death due to any cause based on the Kaplan-Meier method .
Measured: 4 years
Association between clinical complete response (cCR) and recurrence-free survival
Estimate association between clinical complete response defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab and recurrence free survival defined as the time from initiation of treatment until the development of invasive local recurrences in the intact bladder based on the Kaplan-Meier method.
Measured: 4 years
Association between clinical complete response (cCR) and metastasis-free survival
Estimate association between clinical complete response defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab and metastasis-free survival defined as the time from initiation of treatment to the development of metastatic disease based on the Kaplan-Meier method.
Measured: 4 years
Association between clinical complete response (cCR) and overall survival
Estimate association between clinical complete response defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab and overall survival defined as the time from initiation of treatment to date of death from any cause based on the Kaplan-Meier method.
Measured: 4 years
Bladder-intact event-free survival
Bladder-intact event-free survival is defined from initiation of treatment until radical cystectomy, evidence of unresectable or metastatic disease, or death due to any cause. Bladder-intact event-free survival will be estimated in patients achieving a clinical complete response.
Measured: 4 years
Pathologic stage
Pathologic stage will be defined based on TNM staging of the cystectomy specimen. Pathologic stage will be explained in patients who did not achieve a clinical complete response and in patients achieving a clinical complete response who subsequently undergo cystectomy.
Measured: 4 years
Metastasis-free survival
Metastasis-free survival is defined as the time from initiation of treatment to the development of metastatic disease. Microscopic metastatic disease involving regional lymph nodes resected at cystectomy performed with curative intent will not be considered an event. Metastasis-free survival will be estimated in patients achieving a clinical complete response, in patients not achieving a clinical complete response, and in the overall cohort.
Measured: 4 years
Overall survival
Overall survival is defined as the time from initiation of treatment to date of death from any cause. Overall survival will be estimated in patients achieving a clinical complete response, in patients not achieving a clinical complete response, and in the overall cohort.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start7 Apr 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Galsky
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc., Astellas Pharma Inc, Merck Sharp & Dohme LLC, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor-investigator, Matthew Galsky, Hoosier Cancer Research Network
- Investigators
- Matthew Galsky, MD, Principal investigator, Sponsor-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809140
- Sponsor's protocol ID
- HCRN-GU22-598
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder
- ClinicalTrials.gov ID
- NCT06809140
- Acronym / sponsor ID
- HCRN-GU22-598
- Keywords
- MIBC, Pembrolizumab, Enfortumab vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Matthew GalskyUniversity, hospital or other
- Collaborators
- Seagen Inc., Astellas Pharma Inc, Merck Sharp & Dohme LLC, Icahn School of Medicine at Mount Sinai
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., >cTa disease) will undergo cystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., >cTa disease) will undergo cystectomy.
| Arm | Type | Receives |
|---|---|---|
| Enfortumab vedotin plus pembrolizumab | Experimental | Drug: Enfortumab vedotin, Drug: PembrolizumabPatients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) plus pembrolizumab (200 mg) followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (defined below) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab (200 mg) will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., >cTa disease) will undergo cystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder clinical stage T2-3N0M0. Participants with mixed histology are eligible provided the urothelial component is ≥50% with the following exceptions: (a) tumors with any degree of squamous differentiation are eligible provided there is a urothelial cancer component, (b) tumors that contain any component of neuroendocrine histology are not eligible. N0 will be considered as the absence of radiographically enlarged lymph nodes on baseline imaging (i.e., Patients with lymph nodes ≥1.5 cm in short axis on imaging are not eligible).
- Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 90 days prior C1D1. A maximal TURBT should be performed when feasible and is defined as a macroscopically complete resection of bladder tumor.
Key exclusion criteria (20 listed)
- Pre-existing sensory or motor neuropathy Grade ≥ 2
- Ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured. Patients with intermediate or lower risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN) risk stratification guidelines may be eligible for enrollment.
- Prior radiation therapy for bladder cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enfortumab vedotin1.25 mg/kg (maximum dose 125 mg) | Drug | Enfortumab vedotin plus pembrolizumab |
| Pembrolizumab200 mg | Drug | Enfortumab vedotin plus pembrolizumab |
Primary outcome
Complete response rate with enfortumab vedotin plus pembrolizumab for MIBC
Time frame: 9 weeks
Clinical complete response rate will be defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab
Bladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response
Time frame: 2 years
Estimate the 2-year bladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response
11 secondary outcomes
Safety of enfortumab vedotin plus pembrolizumab
Time frame: 2 years
Positive predictive value (PPV) of cCR Patients
Time frame: 2 years
Local recurrence-free survival
Time frame: 4 years
Association between clinical complete response (cCR) and bladder-intact event-free survival
Time frame: 4 years
Association between clinical complete response (cCR) and recurrence-free survival
Time frame: 4 years
Association between clinical complete response (cCR) and metastasis-free survival
Time frame: 4 years
Association between clinical complete response (cCR) and overall survival
Time frame: 4 years
Bladder-intact event-free survival
Time frame: 4 years
Pathologic stage
Time frame: 4 years
Metastasis-free survival
Time frame: 4 years
Overall survival
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Galsky, MD principal investigator
Sponsor-Investigator
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enfortumab vedotin and Pembrolizumab in people with Muscle Invasive Bladder Urothelial Carcinoma, run by Matthew Galsky at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Galsky, MD (212-659-5452, matthew.galsky@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate with enfortumab vedotin plus pembrolizumab for MIBC (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.