Enfortumab Vedotin for Bladder Cancer
(EV-103 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called enfortumab vedotin alone and with other treatments in patients with advanced or muscle-invasive bladder cancer. The goal is to see how well these treatments work and what side effects they might have. Enfortumab vedotin targets and kills cancer cells, while pembrolizumab helps the immune system fight the cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on high doses of steroids or other immunosuppressive medications, you may not be eligible to participate.
What data supports the effectiveness of the drug Enfortumab Vedotin for bladder cancer?
Enfortumab Vedotin has been approved by the FDA for treating advanced bladder cancer after other treatments have been tried, based on a study showing a 44% response rate in patients, with some experiencing complete tumor disappearance. The drug is used when previous treatments, including certain immunotherapies and chemotherapy, have not been successful.12345
Is Enfortumab Vedotin safe for humans?
Enfortumab Vedotin has been shown to have a tolerable safety profile in patients with advanced bladder cancer, but it can cause serious side effects like high blood sugar, nerve damage, eye problems, skin reactions, and risks to unborn babies. In a study, 73% of patients experienced severe side effects.12346
How is the drug Enfortumab Vedotin unique for treating bladder cancer?
Enfortumab Vedotin is unique because it is the first drug approved to treat advanced bladder cancer in patients who have already received other treatments like PD-1/PD-L1 inhibitors and platinum-based chemotherapy. It works as an antibody-drug conjugate targeting Nectin-4, a protein found on cancer cells, and is given through an IV on a specific schedule.12378
Research Team
Changting Meng, MD
Principal Investigator
Seagen Inc.
Jason Lukas, MD, PhD
Principal Investigator
Seagen Inc.
Eligibility Criteria
This trial is for adults with advanced or muscle-invasive urothelial cancer, including bladder and other urinary cancers. Participants should be eligible for certain chemotherapy drugs like cisplatin or carboplatin, and some may also qualify for pembrolizumab treatment. They must not have received specific prior treatments, have a good performance status (able to carry out daily activities), and an expected lifespan of at least 3 months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive enfortumab vedotin alone or in combination with pembrolizumab to determine the safety and tolerability
Expansion
Participants are treated in various cohorts to evaluate the efficacy of enfortumab vedotin in combination with other therapies
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Cisplatin
- Enfortumab Vedotin
- Gemcitabine
- Pembrolizumab
Enfortumab Vedotin is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic urothelial cancer
- Locally advanced or metastatic urothelial cancer
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
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
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