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Antibody-drug conjugate
Enfortumab Vedotin + Pembrolizumab for Bladder Cancer
Phase 2
Waitlist Available
Led By Jean Hoffman-Censits, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must refuse definitive radical nephroureterectomy (RNU), or be medically ineligible for surgery
Subjects must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial will test a combo of drugs for patients with UTUC who don't want surgery. It will see if the drugs can give outcomes similar to surgery.
Who is the study for?
This trial is for adults with high grade upper tract urothelial cancer who haven't had systemic therapy for advanced cancer, are opting out of or can't have surgery, and don’t have metastatic disease. Participants must be in good health otherwise, able to consent, and meet specific conditions if they can have children.Check my eligibility
What is being tested?
The study tests combining pembrolizumab and enfortumab vedotin as a treatment option instead of standard surgery. It aims to see if this drug combo can lead to survival rates similar to those achieved by the usual surgical procedure without spreading the cancer.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, fatigue, rash, loss of appetite, changes in taste sensation, hair loss from chemotherapy drugs like enfortumab vedotin; immune-related effects such as inflammation in organs may occur with pembrolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot or choose not to have major surgery to remove my kidney and ureter.
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I have not had any treatment for advanced bladder cancer.
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I am 18 or older with a confirmed diagnosis of high-grade upper tract urothelial cancer.
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My cancer has not spread to other parts of my body or lymph nodes.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event free survival (EFS)
Secondary outcome measures
Glomerular Filtration Rate (GFR)
Other outcome measures
Overall Survival
Progression free survival
To assess feasibility of obtaining immune biomarker data from UTUC biopsy specimens
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Enfortumab vedotin with PembrolizumabExperimental Treatment2 Interventions
The study population will include male and female patients over the age of 18 with high grade UTUC (cN0/xM0) and is ineligible for or refuses definitive radical nephroureterectomy (RNU).
Enfortumab vedotin will be administered on Days 1 and 8 at 1.25mg/kg of every 3-week cycle by intravenous (IV) infusion given over approximately 30 minutes. Pembrolizumab will be administered on Day 1 at 200mg of every 3-week cycle by IV infusion over approximately 30 minutes. Enfortumab vedotin and Pembrolizumab may be administered for up to total of 35 cycles (approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enfortumab vedotin
2017
Completed Phase 2
~240
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,899 Total Patients Enrolled
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,380 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,126 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke or similar brain event in the last 6 months.I have not had radiotherapy in the last 2 weeks.I have another cancer besides non-melanoma skin cancer or prostate cancer that is not actively growing.You are not expected to live for more than 12 weeks.I have moderate to severe numbness, tingling, or muscle weakness.You have been diagnosed with HIV.I am on high doses of steroids or other drugs that weaken my immune system.I cannot or choose not to have major surgery to remove my kidney and ureter.I have not had any treatment for advanced bladder cancer.You have had a transplant using cells or organs from another person.I have not received a live vaccine in the last 30 days.I have active tuberculosis.I am 18 or older with a confirmed diagnosis of high-grade upper tract urothelial cancer.I am a woman who can have children and meet specific health conditions.I am a man who can father children and agree to follow specific guidelines.I have not had major surgery in the last 4 weeks.I have previously received enfortumab vedotin or similar drugs.I have been treated with a PD-(L)-1 inhibitor for cancer.My diabetes is not under control.My blood and organ tests meet the required health standards.My cancer has not spread to other parts of my body or lymph nodes.I am fully active or can carry out light work.I have an active eye infection or corneal ulcer.I have been treated for an autoimmune disease in the last 2 years.You have had a strong allergic reaction (Grade 3 or higher) to certain ingredients in the drug.You have another health condition that would make it difficult for you to receive or tolerate the planned treatment and follow-up.I am experiencing severe side effects from previous cancer treatments.I am currently on medication for an infection.I have an active hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Enfortumab vedotin with Pembrolizumab
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.
Has the combination of Enfortumab vedotin and Pembrolizumab been certified by the FDA?
"The safety of the Enfortumab vedotin with Pembrolizumab combination was rated a 2 due to on-going Phase 2 trials, which have demonstrated some indications of its security but not yet confirmed efficacy."
Answered by AI
Are there any opportunities to participate in this experiment at present?
"According to the data found on clinicaltrials.gov, this trial is not currently recruiting participants since it was last updated in December of 2022. Nevertheless, there are over two thousand seven hundred ninety-three other studies that presently require individuals for their trials."
Answered by AI
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