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Taxane
Enfortumab Vedotin vs Chemotherapy for Bladder Cancer
Phase 3
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has ECOG PS of 0 or 1
Subject must have received a platinum containing regimen (cisplatin or carboplatin) in the metastatic/locally advanced, neoadjuvant or adjuvant setting. If platinum was administered in the adjuvant/neoadjuvant setting subject must have progressed within 12 months of completion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment (eot) (median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
Awards & highlights
Study Summary
This trial found that enfortumab vedotin significantly improves overall survival compared to chemotherapy in patients with locally advanced or metastatic urothelial cancer.
Who is the study for?
Adults with advanced or metastatic urothelial cancer who have previously been treated with a checkpoint inhibitor and a platinum-containing regimen. They must not be candidates for curative surgery, have acceptable organ function, agree to contraception if of childbearing potential, and cannot be breastfeeding or pregnant. Exclusions include certain preexisting conditions like neuropathy Grade ≥2, recent other cancers, active infections requiring systemic treatment, specific viral infections (HIV/Hepatitis B/C), recent cardiovascular events, untreated brain metastases among others.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Enfortumab Vedotin compared to standard chemotherapy drugs (Docetaxel, Vinflunine, Paclitaxel) in improving overall survival rates for patients with urothelial cancer. It also examines progression-free survival rates, response rates to treatment according to RECIST V1.1 criteria and evaluates safety/tolerability along with quality of life outcomes.See study design
What are the potential side effects?
Enfortumab Vedotin may cause side effects such as fatigue; skin reactions; neuropathy; blood sugar changes; gastrointestinal symptoms like nausea or diarrhea; liver enzyme elevations; low blood cell counts leading to increased infection risk or bleeding problems. Chemotherapy can cause similar issues plus hair loss and an increased chance of developing long-term health problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I've had platinum-based treatment for my cancer and it progressed within a year.
Select...
My cancer has spread or is advanced, confirmed by scans.
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I have been diagnosed with a type of bladder or urinary tract cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment (eot) (median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment (eot) (median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score)
Disease Control Rate (DCR) as Per RECIST V1.1
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cross-over Extension (COE)Experimental Treatment1 Intervention
Eligible participants from chemotherapy arm who met the criteria for COE will receive 1.25 mg/kg of body weight enfortumab vedotin by intravenous infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle until discontinuation criteria is met.
Group II: Arm A: Enfortumab Vedotin 1.25 mg/kgExperimental Treatment1 Intervention
Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Group III: Arm B: ChemotherapyActive Control3 Interventions
Participants received either 75 milligrams per square meter (mg/m^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 1 hour on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
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Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,454 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
68,549 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,062,872 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had platinum-based treatment for my cancer and it progressed within a year.I am allergic to certain cancer drugs like docetaxel, paclitaxel, or vinflunine.My diabetes has been under control for the last 3 months.I have a known history of HIV infection.I've had more than one chemotherapy for advanced bladder cancer or if it came back within a year after treatment.I haven't had cancer, except for certain skin, prostate cancers, or fully removed in-situ cancers, in the last 3 years.I am on medication for an infection but not just as a preventive measure.I have active Hepatitis B or C.You are allergic to EV or any ingredients in the drug, or allergic to biopharmaceuticals made in Chinese hamster ovary cells.I am fully active or restricted in physically strenuous activity but can do light work.I don't have severe side effects from previous cancer treatments, except for manageable thyroid issues.I have been treated with EV or similar drugs before.I have stable brain metastases and am not on high doses of steroids.I've had a stroke, heart attack, or severe heart symptoms in the last 6 months.I am legally an adult and can give consent.I haven't had radiotherapy or major surgery in the last 4 weeks.I have an active eye infection or corneal ulcer.My cancer has spread or is advanced, confirmed by scans.I finished any cancer treatments at least 2 weeks before starting the study drug.My cancer worsened after or during treatment with a checkpoint inhibitor, and surgery isn't an option.I have moderate to severe nerve damage affecting my senses or movement.I have been diagnosed with a type of bladder or urinary tract cancer.Your blood counts, liver and kidney function, and other test results should be within certain normal ranges.I have had chemotherapy for bladder cancer with all drugs available in the study.I do not have any health conditions that would stop me from receiving or handling the planned treatment.I can provide a tissue sample from my tumor for testing before treatment starts.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Enfortumab Vedotin 1.25 mg/kg
- Group 2: Arm B: Chemotherapy
- Group 3: Cross-over Extension (COE)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Enfortumab Vedotin a new medication?
"City of Hope Comprehensive Cancer Center was the first to study enfortumab vedotin in 1997 and, since then, there have been a total of 1907 completed trials. As of now, 1159 studies are actively recruiting patients with many clinical trial sites located in Sacramento and Connecticut."
Answered by AI
What are Enfortumab Vedotin's standard indications?
"Enfortumab Vedotin is the standard of care for neoplasm metastasis, but can also be used to treat other conditions such as STS, locally advanced NSCLC, and metastatic bladder cancer."
Answered by AI
Are there different locations where this clinical trial is taking place in the city?
"Currently, the trial is running in 36 hospitals. The locations of these facilities are situated in Sacramento, New Haven, Seattle and 33 other cities. If you enroll in this program, it would be best to select a site that is closest to your location to reduce travel time and costs."
Answered by AI
Could you please walk me through the risks of Enfortumab Vedotin?
"Enfortumab Vedotin's safety is estimated to be a 3. This is because it has reached Phase 3 in clinical trials, meaning that efficacy has been supported by some data and multiple rounds of safety testing have been completed."
Answered by AI
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