Enfortumab Vedotin + Pembrolizumab vs. Chemotherapy for Bladder Cancer
(EV-302 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received certain cancer treatments recently, and you cannot be on systemic antimicrobial treatment for an active infection at the time of randomization.
Is the combination of Enfortumab Vedotin and Pembrolizumab safe for humans?
The combination of Enfortumab Vedotin and Pembrolizumab has been studied in patients with advanced urothelial cancer and is generally well tolerated. Common side effects include skin issues, fatigue, and high blood sugar, which are usually manageable with care and dose adjustments. However, peripheral neuropathy (nerve damage) can be a limiting factor, and rare serious skin reactions have been reported.12345
What makes the drug combination of Enfortumab Vedotin and Pembrolizumab unique for bladder cancer?
What data supports the effectiveness of the drug combination Enfortumab Vedotin and Pembrolizumab for bladder cancer?
Research shows that both Enfortumab Vedotin and Pembrolizumab have individually improved survival in urothelial cancer, and their combination is being studied as a first-line treatment for patients who cannot use cisplatin. Enfortumab Vedotin has shown response rates of 40% to 52% in patients with advanced urothelial cancer, including those with poor prognosis.12378
Who Is on the Research Team?
Zejing Wang, MD, PhD
Principal Investigator
Seagen Inc.
John Lu, MD
Principal Investigator
Seagen Inc.
Are You a Good Fit for This Trial?
This trial is for adults with advanced urothelial cancer that has spread, who can handle cisplatin or carboplatin chemo and haven't had certain treatments before. They need to have a performance status score of 0-2, which means they're up and about more than half the day.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enfortumab vedotin and pembrolizumab or standard chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Enfortumab vedotin
- Gemcitabine
- Pembrolizumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available
Seagen Inc.
Industry Sponsor
Dr. Roger Dansey
Seagen Inc.
Chief Medical Officer since 2018
MD from University of Witwatersrand
David R. Epstein
Seagen Inc.
Chief Executive Officer since 2022
BSc in Pharmacy from Rutgers University, MBA from Columbia University
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University