Enfortumab Vedotin + Pembrolizumab for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two different treatment plans for advanced bladder cancer. One group receives enfortumab vedotin (an antibody-drug conjugate) alone, while the other receives a combination of enfortumab vedotin and pembrolizumab (an immunotherapy drug). The goal is to determine if altering the frequency of these drugs can better control the cancer. The trial seeks participants with advanced bladder cancer who have completed other treatments and have measurable cancer on scans. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial requires that any prior systemic therapy must be completed at least 14 days before starting the study treatment. However, the protocol does not specify if you need to stop other current medications, so it's best to discuss this with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Enfortumab Vedotin, when used alone, is approved for treating advanced bladder cancer after other treatments have failed. This indicates it has undergone safety testing in people. Some patients experience side effects like tiredness and skin rash, but it is generally well-tolerated.
Studies have also shown that the combination of Enfortumab Vedotin with Pembrolizumab is approved for treating advanced bladder cancer. This suggests that using both drugs together is considered safe. Patients have reported side effects such as tiredness and nausea, which are common with cancer treatments.
Since this trial is in an early stage, it aims to further confirm the effectiveness and safety of these treatments. Participants should be aware that while previous data shows the treatments are generally safe, risks may still exist.12345Why are researchers excited about this trial's treatments?
Researchers are excited about enfortumab vedotin and pembrolizumab for bladder cancer because these treatments introduce a fresh approach compared to standard options like chemotherapy or immune checkpoint inhibitors alone. Enfortumab vedotin is an antibody-drug conjugate that specifically targets and delivers chemotherapy to cancer cells, potentially reducing side effects and increasing effectiveness. Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. When used together, they may offer a more powerful one-two punch against bladder cancer, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research has shown that enfortumab vedotin, which participants in this trial may receive as monotherapy, can help people with advanced bladder cancer live longer. In one study, 4.9% of patients experienced complete cancer remission, and 35.8% saw their cancer shrink. Another group in this trial will receive enfortumab vedotin combined with pembrolizumab. This combination lowered the risk of death by 49% compared to standard chemotherapy. Another study found that this combination works better than chemotherapy alone for those not yet treated for advanced cancer. These findings suggest that using enfortumab vedotin alone or with pembrolizumab can effectively treat bladder cancer.23678
Who Is on the Research Team?
Pooja Ghatalia, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
Adults with advanced or metastatic urothelial cancer, who have measurable disease and are planning to receive Enfortumab Vedotin (EV) as standard treatment. They must be over 18, have finished any prior systemic therapy at least two weeks before, and be in a fair to good physical state (ECOG 0-2). Participants need normal organ/marrow function and must provide a tumor tissue sample if available.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 (EV) monotherapy or EV in combination with pembrolizumab. EV monotherapy is administered at a standard dose of 1.25 mg/kg IV on days 1, 8, and 15 of a 28-day cycle for 3 cycles. EV/pembrolizumab is administered with EV at a standard dose of 1.25 mg/kg IV on days 1 and 8, and pembrolizumab 200 mg IV on day 1 of a 21-day cycle for 6 cycles.
Schedule De-escalation
First schedule de-escalation occurs for patients with disease control at 12 weeks for EV monotherapy and at 9 weeks for EV/pembrolizumab. Second schedule de-escalation occurs at 24 weeks for EV monotherapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Overall survival and time to next treatment are assessed over a 5-year period.
What Are the Treatments Tested in This Trial?
Interventions
- Enfortumab Vedotin
- 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?
Fox Chase Cancer Center
Lead Sponsor