Actively Recruiting
A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-03-06
100
Participants Needed
10
Research Sites
131 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
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
Official Title
A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed urothelial carcinoma including bladder, renal pelvis, ureter, or urethra
- Experienced disease progression or relapse during or after checkpoint inhibitor therapy for locally advanced or metastatic disease
- Received platinum-containing chemotherapy in metastatic, locally advanced, neoadjuvant, or adjuvant setting
- Measurable metastatic or locally advanced disease at baseline based on RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Baseline laboratory tests meet protocol requirements
- Female participants not pregnant and either not of childbearing potential or with negative pregnancy test and agreeing to contraceptive guidance
- Female participants not breastfeeding or lactating during and for 6 months after treatment
- Female participants must not donate ova during and for 6 months after treatment
- Male participants agree to use contraception or abstain during treatment and for 6 months after
- Male participants must not donate sperm during and for 6 months after treatment
- Agreement not to participate in another interventional study during treatment
You will not qualify if you...
- Preexisting sensory or motor neuropathy grade 2 or higher
- Active central nervous system metastases unless clinically stable for 6 weeks with stable low-dose steroids and no new or enlarged brain metastases
- Leptomeningeal disease
- Ongoing clinically significant toxicity grade 2 or higher from prior treatments except alopecia
- Ongoing grade 3 or higher immunotherapy-related hypothyroidism or panhypopituitarism
- Ongoing immunotherapy-related colitis, uveitis, myocarditis, pneumonitis or other adverse events requiring high-dose steroids
- History of other malignancy within 3 years except certain low-risk cancers
- Positive hepatitis B surface antigen or core antibody without proper prophylaxis
- Active hepatitis C or HIV infection unless treated and with sustained response
- Recent serious cardiovascular events within 6 months
- Known active keratitis or corneal ulcerations
- Other medical conditions impairing ability to receive or tolerate treatment
- Uncontrolled diabetes mellitus within 3 months
- Prior treatment with enfortumab vedotin or similar antibody drug conjugates
- Receiving systemic antimicrobial treatment for infections at first dose
- Recent radiotherapy or major surgery within 4 weeks
- Recent chemotherapy, biologics, immunotherapy within 2 weeks
- Known hypersensitivity to enfortumab vedotin or its components
- Any condition making participant unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Site IN91015
Kochi, Kerala, India
Actively Recruiting
2
Site IN91004
Mumbai, Maharashtra, India
Actively Recruiting
3
Site IN91016
New Delhi, National Capital Territory of Delhi, India
Actively Recruiting
4
Site IN91017
Dumas, Surat, India
Actively Recruiting
5
Site IN91005
Varanasi, Uttar Pradesh, India
Actively Recruiting
6
Site IN91012
Ahmedabad, India
Actively Recruiting
7
Site IN91010
Bhubaneswar, India
Actively Recruiting
8
Site IN91008
Mumbai, India
Actively Recruiting
9
Site IN91009
Nagpur, India
Actively Recruiting
10
Site IN91001
Surat, India
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
CONTACT
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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