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 trial explores the effectiveness of combining two drugs, enfortumab vedotin and pembrolizumab, to treat bladder cancer that has spread beyond the urinary system. It aims to determine if these drugs are more effective than standard chemotherapy treatments. Suitable participants have advanced bladder cancer that cannot be surgically removed and have not received certain prior treatments. As a Phase 3 trial, this study represents the final step before FDA approval, providing patients with access to potentially groundbreaking treatment.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using enfortumab vedotin and pembrolizumab together may help treat certain bladder cancers. Studies have found that this combination can lead to better results for patients compared to traditional chemotherapy.
Regarding safety, enfortumab vedotin and pembrolizumab are generally well-tolerated. Clinical studies report common side effects such as tiredness, skin rash, and changes in blood cell counts, while serious side effects occur less frequently. This suggests the combination might be a safe option for many patients.
Both enfortumab vedotin and pembrolizumab have been widely studied in other contexts. The FDA has already approved pembrolizumab for several types of cancer, which enhances understanding of its safety. While every treatment carries risks, current evidence supports the safety of these drugs in the studied groups.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Enfortumab vedotin combined with pembrolizumab for bladder cancer because it introduces a novel approach to treatment. Unlike traditional chemotherapy, Enfortumab vedotin is an antibody-drug conjugate targeting a protein called Nectin-4, which is prevalent on bladder cancer cells. This targeted delivery allows for more direct cancer cell destruction while potentially sparing healthy cells. Pembrolizumab, on the other hand, is an immunotherapy that helps the immune system recognize and attack cancer cells. Together, these treatments offer a promising alternative to standard chemotherapy regimens like gemcitabine with cisplatin or carboplatin, potentially leading to improved outcomes for patients.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research shows that the combination of enfortumab vedotin and pembrolizumab, which participants in this trial may receive, holds promise for treating advanced bladder cancer. Earlier studies found that this combination reduced the risk of death by 50% and extended patient survival. Tumors shrank or stopped growing in about 67% of patients who received these drugs. Many patients experienced positive outcomes, with some achieving partial or complete recovery. This evidence suggests that this drug combination may effectively manage advanced bladder cancer. Meanwhile, another group in this trial will receive a chemotherapy regimen of gemcitabine with either cisplatin or carboplatin, serving as the active comparator.26789
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:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular 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
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