Metastatic Urothelial CarcinomaPhase 4NCT06862219
A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
A Phase 4 study testing Enfortumab Vedotin in people with Metastatic Urothelial Carcinoma, run by Astellas Pharma Global Development, Inc. at 15 sites in India.
Trial summary
This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Urothelial Carcinoma
- What is being tested?
- Enfortumab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 15 sitesIndia
- Study dates
- 21 Jun 2025to 31 Dec 2027
- Phase
- Phase 4
- 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
- Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra). Participants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible.
- Participant must have experienced radiographic progression or relapse during or after a checkpoint inhibitor (CPI) (anti-PD-1 or anti-PD-L1) for locally advanced (LA) or metastatic disease. Participants who discontinued CPI treatment due to toxicity are eligible provided that they have evidence of disease progression following discontinuation. The CPI need not be the most recent therapy. Participants for whom the most recent therapy has been a non-CPI based regimen are eligible if they have progressed / relapsed during or after their most recent therapy. LA disease must not be amenable to resection with curative intent.
- Participant must have received a platinum-containing regimen (cisplatin or carboplatin) in the metastatic / LA, neoadjuvant or adjuvant setting. If platinum was administered in the ajuvant/neoadjuvant setting, the participant must have progressed within 12 months of completion.
- Participant must have measurable metastatic or LA disease at baseline according to RECIST version 1.1.
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participant's baseline laboratory data meets protocol specified of criteria.
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- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who has a negative urine or serum pregnancy test at screening or within 7 days prior to day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for approximately 6 months after final study intervention administration.
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 6 months after final study intervention administration.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final study intervention administration.
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final study intervention administration.
- Male participant must not donate sperm during the treatment period and for 6 months after final study intervention administration.
- Participant agrees not to participate in another interventional study while receiving study intervention in the present study.
Who cannot join
- Participant has preexisting sensory or motor neuropathy grade ≥ 2.
- Participant has active central nervous system (CNS) metastases. Participant with treated CNS metastases is permitted on study if all the following are true:
- CNS metastases have been clinically stable for at least 6 weeks prior to screening
- If requiring steroid treatment for CNS metastases, the participant is on a stable dose ≤ 20 mg/day of prednisone or equivalent for at least 2 weeks
- Baseline scans show no evidence of new or enlarged brain metastasis
- Participant does not have leptomeningeal disease
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- Participant has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Participant with ≤ grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well-maintained / controlled on a stable dose of hormone replacement therapy (HRT) (if indicated).
- Participant with ongoing ≥ grade 3 immunotherapy-related hypothyroidism or panhypopituitarism are excluded.
- Participant with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or participant with other immunotherapy-related AEs requiring high doses of steroids (> 20 mg/day of prednisone or equivalent) are excluded.
- Participant has history of another malignancy within 3 years before the first dose of study intervention or any evidence of residual disease from a previously diagnosed malignancy.
- Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance / watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
- Participant with a positive hepatitis B surface antigen and/or anti-hepatitis B core antibody and a negative polymerase chain reaction assay at baseline should receive appropriate antiviral prophylaxis or regular surveillance monitoring as per local or institutional guidelines.
- Participant has active hepatitis C infection or known human immunodeficiency virus infection. Participant who has been treated for hepatitis C infection is permitted if they have documented sustained virologic response of ≥ 12 weeks.
- Participant has documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III to IV within 6 months prior to the first dose of study intervention administration.
- Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.
- Participant has other underlying medical condition that would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.
- Participant has history of uncontrolled diabetes mellitus within 3 months of the first dose of study intervention. Uncontrolled diabetes is defined as HbA1c ≥ 8 percent or HbA1c between 7 percent and < 8 percent with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
- Participant has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody drug conjugate (ADCs).
- Participant is currently receiving systemic antimicrobial treatment for viral, bacterial, or fungal infection at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
- Participant has radiotherapy or major surgery within 4 weeks prior to first dose study intervention administration.
- Participant has had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study intervention administration.
- Participant has any condition which makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20); OR participant has known hypersensitivity to biopharmaceuticals produced in CHO cells.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
India15 sites, 15 recruiting
- Recruiting
Site IN91012
Ahmedabad
- Recruiting
Site IN91010
Bhubaneswar
- Recruiting
Site IN91018
Delhi
- Recruiting
Site IN91021
Delhi
- Recruiting
Site IN91017
Dumas, Surat
- Recruiting
Site IN91015
Kochi, Kerala
- Recruiting
Site IN91006
Kolkata, West Bengal
- Recruiting
Site IN91004
Mumbai, Maharashtra
- Recruiting
Site IN91008
Mumbai
- Recruiting
Site IN91009
Nagpur
- Recruiting
Site IN91016
New Delhi, National Capital Territory of Delhi
- Recruiting
Site IN91013
Patna, Bihar
- Recruiting
Site IN91001
Surat
- Recruiting
Site IN91005
Varanasi, Uttar Pradesh
- Recruiting
Site IN91007
Vellore, Tamil Nadu
About this study
Official title: A Multicenter, Phase 4, Open-label, Single-arm, Safety Study of Enfortumab Vedotin in Adult Indian Participants With Previously Treated Locally Advanced or Metastatic Urothelial Cancer
This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer.
The main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer.
Read more
During the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle.
People visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.
- Conditions
- Metastatic Urothelial Carcinoma
- Being tested
- Enfortumab Vedotin
- Keywords
- PADCEV, ASG-22CE, Urothelial cancer, Enfortumab Vedotin
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfortumab VedotinDrug
Also called ASG-22CE, PADCEV
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Enfortumab Vedotin (EV) - All participants | Experimental | Participants will receive enfortumab vedotin (EV) on days 1, 8 and 15 of each 28 day cycle. Receives: Drug: Enfortumab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Adverse events (AE) will be coded using MedDRA. An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Measured: Up to 8 months
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 7 months
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 7 months
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Measured: Up to 6.5 months
Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) Performance Status score
The ECOG scale will be used to assess performance status. Scores range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Measured: Up to 7 months
Secondary outcomes (2)
Confirmed Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) per investigator assessment
ORR is defined as the proportion of participants whose best overall response is a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1 per investigator assessment
Measured: Up to 34 months
Duration of Response (DOR) according to RECIST version 1.1 per investigator assessment
DOR is defined as the time from the date of the first documented response (CR or PR that is subsequently confirmed) per RECIST version 1.1 as determined by investigator to the date of first documented radiological disease progression per RECIST version 1.1 or death, whichever occurs first.
Measured: Up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start21 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CarcinomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862219
- Sponsor's protocol ID
- 7465-CL-4001
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 4, Open-label, Single-arm, Safety Study of Enfortumab Vedotin in Adult Indian Participants With Previously Treated Locally Advanced or Metastatic Urothelial Cancer
- ClinicalTrials.gov ID
- NCT06862219
- Acronym / sponsor ID
- 7465-CL-4001
- Conditions
- Metastatic Urothelial Carcinoma
- Keywords
- PADCEV, ASG-22CE, Urothelial cancer, Enfortumab Vedotin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 21 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 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.
This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer.
The main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer.
During the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle.
People visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Enfortumab Vedotin (EV) - All participants | Experimental | Drug: Enfortumab VedotinParticipants will receive enfortumab vedotin (EV) on days 1, 8 and 15 of each 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra). Participants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible.
- Participant must have experienced radiographic progression or relapse during or after a checkpoint inhibitor (CPI) (anti-PD-1 or anti-PD-L1) for locally advanced (LA) or metastatic disease. Participants who discontinued CPI treatment due to toxicity are eligible provided that they have evidence of disease progression following discontinuation. The CPI need not be the most recent therapy. Participants for whom the most recent therapy has been a non-CPI based regimen are eligible if they have progressed / relapsed during or after their most recent therapy. LA disease must not be amenable to resection with curative intent.
- Participant must have received a platinum-containing regimen (cisplatin or carboplatin) in the metastatic / LA, neoadjuvant or adjuvant setting. If platinum was administered in the ajuvant/neoadjuvant setting, the participant must have progressed within 12 months of completion.
- Participant must have measurable metastatic or LA disease at baseline according to RECIST version 1.1.
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (24 listed)
- Participant has preexisting sensory or motor neuropathy grade ≥ 2.
- Participant has active central nervous system (CNS) metastases. Participant with treated CNS metastases is permitted on study if all the following are true:
- Participant has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Participant has history of another malignancy within 3 years before the first dose of study intervention or any evidence of residual disease from a previously diagnosed malignancy.
- Participant with a positive hepatitis B surface antigen and/or anti-hepatitis B core antibody and a negative polymerase chain reaction assay at baseline should receive appropriate antiviral prophylaxis or regular surveillance monitoring as per local or institutional guidelines.
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: ASG-22CE, PADCEVIntravenous infusion | Drug | Experimental: Enfortumab Vedotin (EV) - All participants |
Primary outcome
Number of participants with Adverse events
Time frame: Up to 8 months
Adverse events (AE) will be coded using MedDRA. An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to 7 months
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and/or AEs
Time frame: Up to 7 months
Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to 6.5 months
Number of participants with potentially clinically significant ECG values.
Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) Performance Status score
Time frame: Up to 7 months
The ECOG scale will be used to assess performance status. Scores range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
2 secondary outcomes
Confirmed Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) per investigator assessment
Time frame: Up to 34 months
Duration of Response (DOR) according to RECIST version 1.1 per investigator assessment
Time frame: Up to 34 months
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 21 Aug 2026.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Monitor study director
Astellas Pharma Global Development, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enfortumab Vedotin in people with Metastatic Urothelial Carcinoma, run by Astellas Pharma Global Development, Inc. at 15 sites in India.
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 15 inclusion and 24 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 21 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 15 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Astellas Pharma Global Development, Inc. (800-888-7704, astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse events (time frame: Up to 8 months). The study lists 5 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 21 Aug 2026.