Enfortumab Vedotin + Pembrolizumab for Bladder Cancer
(IMPROEV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for individuals with advanced bladder cancer that cannot be surgically removed. The study aims to assess the effectiveness of combining two drugs, enfortumab vedotin (an antibody-drug conjugate) and pembrolizumab (an immunotherapy), in shrinking tumors. Participants will receive these drugs for about 18 weeks. If the cancer responds well, they may continue with one of the drugs as ongoing therapy. This trial seeks participants with advanced bladder cancer who have not previously received chemotherapy for their metastatic condition. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on high-dose steroids or certain treatments for active infections, you may not be eligible. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study tested the safety of combining enfortumab vedotin and pembrolizumab in patients with advanced bladder cancer. This study included 442 patients who received the treatment. Researchers found that most patients tolerated it well, without severe problems. Some patients experienced side effects, but these were usually manageable. The combination treatment helped patients live longer compared to other treatments, indicating its effectiveness and safety. While all treatments can cause side effects, evidence suggests this combination offers a good balance of safety and effectiveness for many patients.12345
Why are researchers excited about this study treatment for bladder cancer?
Researchers are excited about Enfortumab Vedotin combined with Pembrolizumab for bladder cancer because it offers a novel approach by targeting specific cancer cells. Enfortumab Vedotin is an antibody-drug conjugate, which means it delivers a powerful chemotherapy agent directly to cancer cells, minimizing damage to healthy cells. This targeted delivery is different from traditional chemotherapies, which can affect both cancerous and normal cells. Additionally, Pembrolizumab is an immune checkpoint inhibitor that helps the body's immune system recognize and attack cancer cells more effectively. Together, these treatments have the potential to enhance effectiveness and reduce side effects compared to standard chemotherapy options.
What evidence suggests that this treatment might be an effective treatment for bladder cancer?
In this trial, participants will receive a combination of enfortumab vedotin and pembrolizumab. Research has shown that this combination can effectively treat metastatic urothelial carcinoma, a type of bladder cancer. Studies found that it can extend patients' lives to an average of 26.7 months, compared to 14.9 months with enfortumab vedotin alone. The treatment also resulted in a 68% rate of tumor shrinkage. In another study, 46.6% of patients experienced partial tumor shrinkage, while 28.3% saw their tumors disappear completely. These findings suggest that this treatment has strong potential to help patients with this cancer.24678
Who Is on the Research Team?
Pooja Ghatalia, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with metastatic urothelial carcinoma who haven't been treated before. They'll receive an initial treatment combo followed by maintenance therapy if they respond well. Specific eligibility details are not provided, but typically include factors like age, health status, and cancer stage.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive enfortumab vedotin and pembrolizumab for 6 cycles (approximately 18 weeks). Radiographic assessments occur after 3 and 6 cycles.
Maintenance
Responding patients receive pembrolizumab every 6 weeks or every 3 weeks for up to 2 years. Radiographic assessments occur every 12 weeks.
Follow-up
Participants enter Survival Follow-up upon progression or toxicity requiring cessation of therapy. Long-term Follow-up for those who discontinue early.
What Are the Treatments Tested in This Trial?
Interventions
- Enfortumab Vedotin
- Pembrolizumab
Trial Overview
The trial tests a combination of enfortumab vedotin (EV) and pembrolizumab (P) as initial therapy for bladder cancer, followed by maintenance with P alone. It's a Phase II study to see how effective this regimen is in new patients over up to two years.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 6 cycles (approximately 18 weeks). EV will be administered at 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle (starting dose of 1 mg/kg allowed), and pembrolizumab at 200 mg IV on Day 1 of each cycle. Patients achieving complete or partial response will transition to maintenance pembrolizumab at 400 mg IV every 6 weeks or 200 mg IV every 3 weeks for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for pembrolizumab. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor
United States Department of Defense
Collaborator
Citations
1.
clinical-genitourinary-cancer.com
clinical-genitourinary-cancer.com/article/S1558-7673(25)00153-3/fulltextReal-World Outcomes of Enfortumab Vedotin and ...
Most patients were male (71.0%) and white (90.7%). The median progression-free survival was 12.9 months (95% CI, 9.5–NE) in Cohort A and 9.3 ...
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 ...
2.5-year median follow-up of the phase III EV-302 ...
The median OS was 33.8 months (95% CI 26.1-39.3 months) for the EV+P arm and 15.9 months (95% CI 13.6-18.3 months) for the chemotherapy arm (HR ...
ASCO GU 2025: Clinical Efficacy of Enfortumab Vedotin + ...
For best overall response, 56 patients (46.6%) experienced partial response, 34 (28.3%) complete response, 12 (10%) progressive disease, 7 (5.8 ...
Enfortumab Vedotin With or Without Pembrolizumab in ...
The findings suggest that enfortumab vedotin, especially combined with pembrolizumab, offers promising beneficial outcomes in metastatic urothelial carcinoma ...
EV-302: Updated analysis from the phase 3 global study of ...
An exploratory analysis evaluated treatment outcomes and safety in pts with cCR. Results: 886 pts were randomized to receive EV+P (n=442) or ...
Exploratory subgroup analyses of EV-302: a phase III ...
Conclusion: Along with previously published safety data, EV+P demonstrated benefit compared with chemotherapy across all prespecified subgroups, ...
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.
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