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Antibody-drug conjugate
Enfortumab Vedotin for Bladder Cancer
Phase 2
Recruiting
Led By Min Yuen Teo, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test a new drug to treat a type of urinary tract cancer, with participants who can't or won't get chemotherapy. Surgery will also be done.
Who is the study for?
This trial is for adults with high-grade urothelial carcinoma of the upper urinary tract who can't or choose not to take cisplatin and are planning on having surgery. They should have adequate kidney function, hearing loss no worse than Grade 2, a good performance status, stable blood counts and liver enzymes, and not be pregnant or breastfeeding. People with uncontrolled diabetes, recent major surgery, active heart disease or infections like tuberculosis or hepatitis B/C cannot join.Check my eligibility
What is being tested?
The study is testing Enfortumab Vedotin's effectiveness and safety in treating cancer before patients undergo standard radical surgery to remove their tumors. It targets those who aren't eligible for cisplatin chemotherapy.See study design
What are the potential side effects?
Enfortumab Vedotin may cause side effects such as fatigue, hair loss, skin rash, decreased appetite, changes in taste sensation, neuropathy (nerve pain), nausea/vomiting/diarrhea/constipation; it also has potential risks of infusion reactions and blood cell count changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who achieve pathologic complete response
Secondary outcome measures
The rate of grade 3 - 4 toxicity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Enfortumab VedotinExperimental Treatment2 Interventions
All patients will receive enfortumab vedotin at 1.25 g/kg on days 1 and 8 of 21 days cycle, for a total of three cycles, followed by radical nephroureterectomy, ureterectomy, or nephrectomy, depending on the site of the tumor and per the clinical decision of the treating urologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radical surgery
2020
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,874 Total Patients Enrolled
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,809 Total Patients Enrolled
Min Yuen Teo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I've had chemo or radiation for bladder cancer in the last 2 years.I had a heart attack in the last 6 months.I am severely allergic to enfortumab vedotin or its ingredients.I have not had major surgery in the last 28 days, except for bladder tumor removal.I have active tuberculosis.I am not pregnant or breastfeeding.I have not had a stroke in the last 6 months.I haven't had any active cancer in the last 2 years, except for early stage cancer that's been cured.I have unstable chest pain.I have a serious wound or fracture that is not healing.I have previously been treated with enfortumab vedotin or similar drugs.I am a male willing to use contraception during and for 31 weeks after treatment.My blood counts and liver function tests are within the required ranges, and if I have HIV, it's under control.I am using reliable birth control and will continue for 23 weeks after my last treatment.I have heart failure that affects my daily activities.I have an eye condition but it's either mild or being treated effectively.I have a specific type of bladder cancer that has not spread beyond my pelvis.My diabetes is not under control, with high HbA1c levels or symptoms like excessive thirst or urination.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have a bleeding or clotting disorder but am on a stable dose of blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Enfortumab Vedotin
Awards:
This trial has 1 awards, including:- 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.
Are there any security concerns when administering Enfortumab Vedotin?
"Enfortumab Vedotin was given a score of 2 on Power's safety scale. This is because, as this trial is still in Phase 2, there are some data confirming its security but no evidence to show that it can be efficacious."
Answered by AI
In how many different places is the investigation taking place?
"Currently, 7 medical sites are taking part in this trial. These include ones based in Middletown, Montvale and Commack as well as other cities across the country. To minimize travel requirements it is advised to pick a site that's closest to you if you decide to join."
Answered by AI
Are there any vacancies still available to prospective participants in this experiment?
"As confirmed on clinicaltrials.gov, this medical trial has ceased its search for participants since the last update was posted on May 11th 2023. Despite no longer enrolling patients, there are over 2500 other trials that still require volunteers at this time."
Answered by AI
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