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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
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-05-28
100
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Astellas Pharma Global Development, Inc.
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating enfortumab vedotin, a treatment for advanced or metastatic urothelial cancer (cancer of the bladder lining), in Indian adults. This phase 4, open-label study aims to confirm the safety of enfortumab vedotin in participants whose cancer has progressed after previous treatments including checkpoint inhibitors and platinum-containing chemotherapy. Participants will receive enfortumab vedotin through intravenous infusion on days 1, 8, and 15 of each 28-day treatment cycle. This single-arm study involves repeated cycles of treatment, with all participants receiving the same study drug. The infusion schedule and dosage are designed to monitor treatment safety and tolerability. Throughout the study, participants will visit the clinic multiple times for health assessments including monitoring of adverse events, laboratory tests, vital signs, and electrocardiograms. Researchers will evaluate safety outcomes up to 8 months and also assess cancer response up to 34 months. The study involves careful tracking of participant health and treatment effects during and after the infusion cycles.
CONDITIONS
Brief Title
A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has histologically or cytologically confirmed urothelial carcinoma (cancer of the bladder, renal pelvis, ureter, or urethra), including transitional cell with squamous or mixed cell types
- Participant has experienced progression or relapse during or after checkpoint inhibitor therapy for locally advanced or metastatic disease
- Participant has received a platinum-containing regimen in metastatic, neoadjuvant, or adjuvant settings; progression within 12 months if platinum was given adjuvantly/neoadjuvantly
- Participant has measurable metastatic or locally advanced disease at baseline per RECIST 1.1
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participant's baseline laboratory data meet protocol criteria
- Female participants are not pregnant and either not women of childbearing potential or have negative pregnancy tests and follow contraceptive guidance
- Female participants must not breastfeed during screening and investigational period plus 6 months after
- Female participants must not donate ova during treatment and 6 months after
- Male participants must use contraception or abstain with partners of childbearing potential during treatment and 6 months after
- Male participants must not donate sperm during treatment and 6 months after
- Participant agrees not to participate in another interventional study while receiving study intervention
You will not qualify if you...
- Participant has preexisting sensory or motor neuropathy grade 2 or higher
- Participant has active central nervous system metastases unless clinically stable for at least 6 weeks with no new or enlarged brain metastasis and no leptomeningeal disease
- Participant has ongoing clinically significant toxicity grade 2 or higher from prior treatment, except controlled hypothyroidism or panhypopituitarism on stable hormone therapy
- Participant has history of another malignancy within 3 years except certain low-risk cancers or carcinoma in situ with complete resection
- Participant with positive hepatitis B markers should follow antiviral prophylaxis or monitoring
- Participant has active hepatitis C or HIV infection; treated hepatitis C patients with sustained response allowed
- Participant has recent severe cardiovascular events within 6 months
- Participant has active keratitis or corneal ulcerations; superficial punctate keratitis allowed if treated
- Participant has medical conditions impairing ability to receive or tolerate treatment
- Participant has uncontrolled diabetes mellitus within 3 months prior, defined by HbA1c thresholds with symptoms
- Participant has prior treatment with enfortumab vedotin or similar antibody-drug conjugates
- Participant is receiving systemic antimicrobial treatment at first dose except routine prophylaxis
- Participant had radiotherapy or major surgery within 4 weeks prior to first dose
- Participant had chemotherapy, biologics, or investigational agents within 2 weeks prior to first dose
- Participant has any condition making them unsuitable for participation
- Participant has known hypersensitivity to enfortumab vedotin or its components including excipients and biopharmaceuticals from CHO cells
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive enfortumab vedotin via intravenous infusion on days 1, 8, and 15 of each 28-day cycle.
3 visits per 28-day cycle (in-person)
Trial Site Locations
Total: 13 locations
1
Site IN91013
Patna, Bihar, India
Actively Recruiting
2
Site IN91015
Kochi, Kerala, India
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3
Site IN91004
Mumbai, Maharashtra, India
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4
Site IN91016
New Delhi, National Capital Territory of Delhi, India
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5
Site IN91017
Dumas, Surat, India
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6
Site IN91007
Vellore, Tamil Nadu, India
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7
Site IN91005
Varanasi, Uttar Pradesh, India
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8
Site IN91006
Kolkata, West Bengal, India
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9
Site IN91012
Ahmedabad, India
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10
Site IN91010
Bhubaneswar, India
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11
Site IN91008
Mumbai, India
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12
Site IN91009
Nagpur, India
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13
Site IN91001
Surat, India
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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