Your session is about to expire
← Back to Search
Antibody-Drug Conjugate
Enfortumab Vedotin + Pembrolizumab for Bladder Cancer
Phase 2
Recruiting
Led By Pooja Ghatalia, MD
Research Sponsored by Fox Chase 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 5 years
Awards & highlights
Study Summary
This trial tests a new way of giving drugs to adults with advanced or metastatic urothelial cancer.
Who is the study for?
Adults with advanced or metastatic urothelial cancer, who have measurable disease and are planning to receive Enfortumab Vedotin (EV) as standard treatment. They must be over 18, have finished any prior systemic therapy at least two weeks before, and be in a fair to good physical state (ECOG 0-2). Participants need normal organ/marrow function and must provide a tumor tissue sample if available.Check my eligibility
What is being tested?
The trial is testing an alternative schedule for administering EV alone and in combination with Pembrolizumab in patients with advanced urothelial cancer. It's an open-label phase 2 study, meaning both researchers and participants know what treatments are given.See study design
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of clinical benefit
Secondary outcome measures
Overall survival
Time to next treatment
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EV/pembrolizumabExperimental Treatment2 Interventions
EV will be administered at standard dose of 1.25 mg/kg IV on days 1 and 8 with pembrolizumab 200 mg IV on day 1 of a 21-day cycle for 6 cycles. Radiographic assessment will be conducted every 9 weeks.
Schedule de-escalation of EV will occur in patients with disease control per RECIST v1.1 (complete response/partial response/stable disease) on their first scan in the EV/pembrolizumab arm at 9 weeks. In these patients EV and pembrolizumab will be administered on day 1 of a 21-day cycle.
Group II: Enfortumab vedotin (EV) monotherapyActive Control1 Intervention
EV will be administered at standard dose of 1.25 mg/kg IV on days 1, 8 and 15 of a 28-day cycle for 3 cycles.
First schedule de-escalation of EV will occur in patients with disease control per RECIST v1.1 (complete response/partial response/stable disease) on their first scan in the EV at 12 weeks. In these patients, EV will be administered on days 1 and 15 of a 28-day cycle.
Second schedule de-escalation of EV will occur in patients with disease control per RECIST v1.1 (complete response/partial response/stable disease) on their second scan in the EV monotherapy (at 24 weeks). EV will be administered on day 1 of a 21-day cycle.
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?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,468 Total Patients Enrolled
Pooja Ghatalia, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
71 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood counts and kidney and liver functions are within normal ranges.My cancer tissue sample is available for testing.My bladder cancer is advanced or has spread, confirmed by tests.I have been treated with MMAE-based drugs for bladder cancer.I have a history of lung scarring or inflammation not caused by infections.I have moderate to severe numbness, tingling, or muscle weakness.I am scheduled to receive EV for advanced bladder cancer.I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.I am HIV-positive and on antiretroviral therapy.My diabetes is not well-controlled (HbA1c over 8%).I am on antibiotics for an infection and about to start enfortumab vedotin.I have had a previous transplant of stem cells or an organ.I have active tuberculosis.I haven't had another cancer that needed treatment in the last 3 years.I finished my last cancer treatment at least 14 days ago.I am older than 18 years.I can take care of myself and perform daily activities.I have untreated brain metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Enfortumab vedotin (EV) monotherapy
- Group 2: EV/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.
Are any vacancies available to volunteer for this experiment?
"According to clinicaltrials.gov, this trial is not currently recruiting participants as it was initially posted on June 25th 2023 and has since been updated for the last time on June 27th of that same year. Although no candidates are being recruited at present, there are an abundance of other medical studies seeking volunteers right now - a total of 2558 trials in all."
Answered by AI
How risky is the administration of EV/pembrolizumab to patients?
"The safety of EV/pembrolizumab was rated a 2 on our assessment scale due to the fact that it is in Phase 2 trials, with existing data validating its security but no evidence yet demonstrating efficacy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger