New Treatments + Enfortumab Vedotin + Pembrolizumab for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for people with urothelial cancer (a type of bladder cancer) that has spread or cannot be removed with surgery. The study aims to determine if adding a new drug, MK-3120, to the standard treatments—enfortumab vedotin (an antibody-drug conjugate) and pembrolizumab (an immunotherapy drug)—is safe and effective in shrinking the cancer. Participants should have advanced or metastatic urothelial cancer and should not have received prior treatment for it. As a Phase 1 trial, this research focuses on understanding how the new treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
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 have HIV, hepatitis B, or hepatitis C, you must have controlled viral loads, which may require continuing your current antiviral treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of enfortumab vedotin and pembrolizumab is generally safe. Studies have found that using this combination as an initial treatment can lead to lasting positive effects and improved survival, particularly for patients unable to take cisplatin, a common chemotherapy drug. The treatment is usually well-tolerated, with new data supporting its safety.
Pembrolizumab alone is also considered safe. In past studies, the most common reasons for stopping treatment were lung inflammation and kidney problems, occurring in a small number of patients. These side effects were neither new nor unexpected.
Both enfortumab vedotin and pembrolizumab have FDA approval for certain cancers, indicating they have passed safety checks for those uses. While no treatment is without risk, current evidence suggests that these medications are generally safe and well-tolerated.12345Why are researchers excited about this trial's treatments?
Most treatments for bladder cancer involve surgery, chemotherapy, or immunotherapy options like BCG or checkpoint inhibitors. However, researchers are excited about the combination of Enfortumab Vedotin and Pembrolizumab because it targets cancer cells with a dual approach. Enfortumab Vedotin is an antibody-drug conjugate, meaning it delivers cancer-killing agents directly to the cancer cells, minimizing damage to healthy cells. Meanwhile, Pembrolizumab is a checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. This combination has the potential to enhance the body's immune response while directly targeting cancer cells, offering hope for more effective and less toxic treatment options.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research has shown that enfortumab vedotin can extend the lives of people with advanced bladder cancer. Studies report that about 49% of patients experienced tumor reduction or disappearance with this drug. In this trial, participants will receive a combination of enfortumab vedotin, pembrolizumab, and MK-3120. When used with pembrolizumab, enfortumab vedotin increased patient survival by 53% on average, with an improvement of about 15.4 months. Pembrolizumab alone has also been shown to extend survival compared to chemotherapy, with about 61% of patients still alive after three years in some studies. These treatments together have shown strong promise in improving outcomes for bladder cancer patients.12678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic urothelial (bladder) cancer who haven't had prior treatment for this stage. Participants must provide a tumor sample and can join if certain viral infections are well controlled.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MK-3120, Enfortumab Vedotin, and Pembrolizumab intravenously on a 3-week cycle until disease progression or discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for long-term outcomes such as Objective Response Rate and Duration of Response
What Are the Treatments Tested in This Trial?
Interventions
- Enfortumab Vedotin
- Pembrolizumab
Trial Overview
The study tests new treatments given alongside standard drugs enfortumab vedotin (EV) and pembrolizumab, to see if the combination is safe and helps shrink or eliminate bladder cancer. Treatments are assigned by chance.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive MK-3120 administered intravenously on Day 1 and Day 8 of each 3-week cycle and EV administered intravenously on Day 1 and Day 8 of each 3-week cycle until documented disease progression or any other discontinuation criterion is met and Pembrolizumab 200 mg administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles (\~2 years).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead 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
Citations
Enfortumab Vedotin in Previously Treated Advanced ...
Enfortumab vedotin significantly prolonged survival as compared with standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma.
Assessing the patient reported outcomes (PROs) of ... - PMC
The investigational arm of EV + pembrolizumab showed a 15.4-month (53% relative improvement) increase in overall survival and 6.2 months increase in progression ...
Real-world comparative outcomes of enfortumab vedotin ...
Overall survival favored EV + Pem, with 12-month survival of 72.5% versus 62.8% (p = 0.017) and 24-month survival of 57.1% versus 48.2% (p = ...
4.
onclive.com
onclive.com/view/real-world-data-show-enfortumab-vedotin-significantly-improved-os-in-urothelial-carcinomaReal-World Data Show Enfortumab Vedotin Significantly ...
Enfortumab vedotin significantly improved outcomes for patients with unresectable or metastatic urothelial carcinoma, according to real-world data.
5.
clinical-genitourinary-cancer.com
clinical-genitourinary-cancer.com/article/S1558-7673(25)00153-3/fulltextReal-World Outcomes of Enfortumab Vedotin and ...
A total of 183 patients with advanced urothelial carcinoma treated with the enfortumab vedotin-pembrolizumab combination were included. The median age at ...
ESMO 2025: EV-103 Cohort K: Efficacy and Safety ...
1st line EV+P continues to demonstrate durable responses, survival benefits, and a manageable safety profile in cisplatin-ineligible patients ...
Survival outcomes with enfortumab vedotin–containing ...
Median overall survival with EV alone was 14.9 months, which increased to 26.7 months with EV+pembrolizumab. •. The objective response rate was 68 % for the ...
EV-302: Updated analysis from the phase 3 global study of ...
TR deaths occurred in 1.1% vs 0.9% of pts in the safety analysis set in the EV+P vs chemo arms, respectively; none occurred in the cCR subgroup.
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