Urinary Bladder NeoplasmsPhase 1NCT05014139
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
A Phase 1 study testing Enfortumab vedotin in people with Urinary Bladder Neoplasms and Carcinoma in Situ, run by Astellas Pharma Global Development, Inc. at 32 sites in 6 countries.
Trial summary
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell
- What is being tested?
- Enfortumab vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 32 sitesin 6 countries
- Study dates
- 7 Dec 2021to 22 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease)
- Predominant histologic component (>50 percent) must be urothelial (transitional cell) carcinoma
- Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive disease, defined as (where adequate BCG therapy is defined as one of the following: 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance therapy or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course):
- Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy.
- Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy, or
- T1 high-grade disease at the first evaluation following an induction BCG course (at least 5 or 6 doses)
Show all 9Show fewer
- Participant must be ineligible for or refusing a radical cystectomy
- All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
- Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.
Who cannot join
- Current or prior history of muscle-invasive urothelial carcinoma or metastatic disease.
- Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months prior to study treatment
- Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram performed within 3 months prior to study treatment
- Prior or concomitant urothelial carcinoma of the prostatic urethra within 6 months prior to study treatment
- Participants with tumor-related hydronephrosis
- Participant has received other systemic anticancer therapy including chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational agent within 4 weeks or intravesical therapy within 6 weeks of first dose of study treatment
- Participant has had any prior radiation to the bladder for urothelial cancer
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States21 sites
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
Erlanger Oncology and Hematology
Chattanooga, Tennessee, 37403
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
James Cancer Hospital / Ohio State University
Columbus, Ohio, 43221
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
MD Anderson
Houston, Texas, 77030
Markey Cancer Center / University of Kentucky
Lexington, Kentucky, 40508
UCLA Department of Medicine - Hematology & Oncology
Los Angeles, California, 90095
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
University of California, Irvine
Orange, California, 92868
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 98682
Urology San Antonio
San Antonio, Texas, 78229
University of California at San Francisco
San Francisco, California, 94134
Mayo Clinic
Scottsdale, Arizona, 85259
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98195
Stanford Health Care
Stanford, California, 94305
Spain4 sites
Site ES34001
Barcelona, 08025
Site ES34004
Barcelona, 08035
Site ES34003
Barcelona, 08036
Site ES34002
Madrid, 28041
France3 sites
Site FR33002
Lyon, 69003
Site FR33001
Paris, 75013
Site FR33003
Rennes, 35000
About this study
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease.
In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
Read the detailed description
The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works.
All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer, NMIBC
- Being tested
- Enfortumab vedotin
- Keywords
- Bladder Cancer, Urothelial Cancer, Enfortumab vedotin, PADCEV, Pharmacokinetics
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfortumab vedotinDrug
Also called PADCEV, ASG-22CE, ASG-22ME
Given into the bladder (intravesically)
| Study group | Role | What they receive |
|---|---|---|
| Enfortumab vedotin: Dose escalation cohort | Experimental | During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses. Receives: Drug: Enfortumab vedotin |
| Enfortumab vedotin: Dose expansion cohort | Experimental | During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses. Receives: Drug: Enfortumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: Approximately 1 year
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
Measured: Approximately 1 year
Incidence of dose limiting toxicities (DLTs)
To be summarized using descriptive statistics.
Measured: Approximately 7 weeks
Secondary outcomes (11)
Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC)
AUC will be recorded from the PK blood samples collected.
Measured: Approximately 1 year
PK of enfortumab vedotin: Maximum concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
Measured: Approximately 1 year
PK of enfortumab vedotin: Time to maximum concentration concentration (tmax)
Tmax will be recorded from the PK blood samples collected.
Measured: Approximately 1 year
PK of enfortumab vedotin: Apparent terminal half-life (t1/2)
T1/2 will be recorded from the PK blood samples collected.
Measured: Approximately 1 year
PK of enfortumab vedotin: Trough concentration (Ctrough)
Ctrough will be recorded from the PK blood samples collected.
Measured: Approximately 1 year
Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin
Blood samples for ATA analysis will be collected.
Measured: Approximately 1 year
Complete response (CR) rate
CR rate is defined as the proportion of subjects achieving CR.
Measured: Up to 24 months
Duration of CR
The time from first documented CR to the first evidence of recurrence, progression, or death due to any cause.
Measured: Up to 3.5 years
Rate of cystectomy
The proportion of subjects who subsequently undergo cystectomy.
Measured: Up to 3.5 years
Progression-free survival
The time from start of study treatment to the first evidence of progression or death due to any cause.
Measured: Up to 3.5 years
Cystectomy-free survival
The time from start of study treatment to cystectomy or death due to any cause.
Measured: Up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start7 Dec 2021
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Why it stopped: Trial was discontinued for strategic reasons. Decision was not based on safety concerns, futility, or request from regulatory authority, ethics committee, or institutional review board or EC/IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seagen, a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014139
- Sponsor's protocol ID
- SGN22E-004
- Other IDs
- EV-104, C5701004, 2023-503388-40-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT05014139
- Acronym / sponsor ID
- SGN22E-004
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer, NMIBC
- Keywords
- Bladder Cancer, Urothelial Cancer, Enfortumab vedotin, PADCEV, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was discontinued for strategic reasons. Decision was not based on safety concerns, futility, or request from regulatory authority, ethics committee, or institutional review board or EC/IRB.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Seagen, a wholly owned subsidiary of Pfizer
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 20 Aug 2021 (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.
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease.
In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
Detailed description
The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works.
All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enfortumab vedotin: Dose escalation cohort | Experimental | Drug: Enfortumab vedotinDuring the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses. |
| Enfortumab vedotin: Dose expansion cohort | Experimental | Drug: Enfortumab vedotinDuring the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease)
- Predominant histologic component (>50 percent) must be urothelial (transitional cell) carcinoma
- Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive disease, defined as (where adequate BCG therapy is defined as one of the following: 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance therapy or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course):
- Participant must be ineligible for or refusing a radical cystectomy
- All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
Key exclusion criteria (7 listed)
- Current or prior history of muscle-invasive urothelial carcinoma or metastatic disease.
- Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months prior to study treatment
- Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram performed within 3 months prior to study treatment
- Prior or concomitant urothelial carcinoma of the prostatic urethra within 6 months prior to study treatment
- Participants with tumor-related hydronephrosis
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 vedotinAlso: PADCEV, ASG-22CE, ASG-22MEGiven into the bladder (intravesically) | Drug | Enfortumab vedotin: Dose escalation cohort, Enfortumab vedotin: Dose expansion cohort |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Approximately 1 year
An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities
Time frame: Approximately 1 year
To be summarized using descriptive statistics.
Incidence of dose limiting toxicities (DLTs)
Time frame: Approximately 7 weeks
To be summarized using descriptive statistics.
11 secondary outcomes
Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC)
Time frame: Approximately 1 year
PK of enfortumab vedotin: Maximum concentration (Cmax)
Time frame: Approximately 1 year
PK of enfortumab vedotin: Time to maximum concentration concentration (tmax)
Time frame: Approximately 1 year
PK of enfortumab vedotin: Apparent terminal half-life (t1/2)
Time frame: Approximately 1 year
PK of enfortumab vedotin: Trough concentration (Ctrough)
Time frame: Approximately 1 year
Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin
Time frame: Approximately 1 year
Complete response (CR) rate
Time frame: Up to 24 months
Duration of CR
Time frame: Up to 3.5 years
Rate of cystectomy
Time frame: Up to 3.5 years
Progression-free survival
Time frame: Up to 3.5 years
Cystectomy-free survival
Time frame: Up to 3.5 years
Results and safety
The study was stopped early (reason given: Trial was discontinued for strategic reasons. Decision was not based on safety concerns, futility, or request from regulatory authority, ethics committee, or institutional review board or EC/IRB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enfortumab vedotin in people with Urinary Bladder Neoplasms and Carcinoma in Situ, run by Astellas Pharma Global Development, Inc. at 32 sites in 6 countries.
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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Spain, France, Germany, Canada and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial was discontinued for strategic reasons. Decision was not based on safety concerns, futility, or request from regulatory authority, ethics committee, or institutional review board or EC/IRB.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Approximately 1 year). The study lists 3 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 14 Sep 2026.