A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

NCT06862219 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 7465-CL-4001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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. 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.

Conditions

Metastatic Urothelial Carcinoma

Keywords

PADCEV; ASG-22CE; Urothelial cancer; Enfortumab Vedotin

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to 8 months

• Number of participants with laboratory value abnormalities and/or AEs

  Number of participants with potentially clinically significant laboratory values.

  Up to 7 months

• Number of participants with vital sign abnormalities and/or AEs

  Number of participants with potentially clinically significant vital sign values.

  Up to 7 months

• Number of participants with electrocardiogram (ECG) abnormalities and/or AEs

  Number of participants with potentially clinically significant ECG values.

  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.

  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

  Up to 34 months

• Duration of Response (DOR) according to RECIST version 1.1 per investigator assessment

  Up to 34 months

Study Arms (1)

Enfortumab Vedotin (EV) - All participants

EXPERIMENTAL

Participants will receive enfortumab vedotin (EV) on days 1, 8 and 15 of each 28 day cycle

Drug: Enfortumab Vedotin

Interventions

Enfortumab Vedotin DRUG

Intravenous Infusion

Also known as: ASG-22CE, PADCEV

Enfortumab Vedotin (EV) - All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Pfizer: collaborator
• Astellas Pharma Global Development, Inc.: lead

Study Sites (10)

Site IN91015

Kochi, Kerala, India

RECRUITING

Site IN91004

Mumbai, Maharashtra, India

RECRUITING

Site IN91016

New Delhi, National Capital Territory of Delhi, India

RECRUITING

Site IN91017

Dumas, Surat, India

RECRUITING

Site IN91005

Varanasi, Uttar Pradesh, India

RECRUITING

Site IN91012

Ahmedabad, India

RECRUITING

Site IN91010

Bhubaneswar, India

RECRUITING

Site IN91008

Mumbai, India

RECRUITING

Site IN91009

Nagpur, India

RECRUITING

Site IN91001

Surat, India

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

enfortumab vedotin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Medical Monitor

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development, Inc.

CONTACT

800-888-7704; astellas.registration@astellas.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 6, 2025
• Study Start: June 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

IN (10)