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Pembrolizumab + Enfortumab Vedotin + Surgery for Bladder Cancer
Study Summary
This trial is studying a combination of two drugs, pembrolizumab and enfortumab vedotin, given together with surgery in people with bladder cancer that has spread to nearby muscle.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My diabetes is not under control.I have had radiation therapy to my bladder before.I have received a transplant from another person.I haven't taken immunosuppressive drugs or high-dose steroids in the last 7 days.My bladder cancer has not spread, as confirmed by scans.You have had a very strong allergic reaction (Grade 3 or higher) to enfortumab vedotin or any of its ingredients.I have had pneumonitis treated with steroids or have it now.My organs are working well.I have been treated with drugs targeting immune checkpoints.I have moderate to severe numbness, tingling, or muscle weakness.I am a male willing to use contraception and not donate sperm for 180 days after my last dose if I receive enfortumab vedotin.I have had treatments like chemotherapy or radiation for bladder cancer.I can take care of myself and am up and about more than half of my waking hours.I am currently on medication for an infection.I am not pregnant or breastfeeding and will not become pregnant or donate eggs for up to 6 months after treatment.I haven't needed systemic therapy for an autoimmune disease in the last 2 years.I have had cancer treatment or been in a cancer study within the last 3 years.You are allergic to monoclonal antibodies or any of their ingredients.I have not received a live vaccine in the last 30 days.I have an eye condition but it's being treated successfully.I have another cancer besides bladder cancer that hasn't needed treatment in the last 3 years.My bladder cancer is confirmed and mostly urothelial type.I had surgery to remove bladder cancer that was not invading the muscle.My cancer has spread to nearby lymph nodes or other parts of my body.I am eligible and agree to undergo surgery to remove my bladder and nearby lymph nodes for cancer treatment.
- Group 1: Arm B: Surgery alone
- Group 2: Arm A: Pembrolizumab + Surgery
- Group 3: Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What conditions does Pembrolizumab help to treat?
"Pembrolizumab can be used as a treatment for patients with malignant neoplasms, unresectable melanoma, or microsatellite instability high."
Are there any more spots open for volunteers in this test?
"The trial, which can be found on clinicaltrials.gov, is currently looking for participants. The study was originally posted on July 24th, 2019 and updated November 15th of this year."
Has Pembrolizumab undergone FDA drug approval?
"Pembrolizumab has received a 3 for safety. This is due to the fact that it is in Phase 3, meaning that efficacy has been supported by some data and multiple rounds have reaffirmed its safety."
Is there a large body of evidence to support Pembrolizumab's efficacy?
"Pembrolizumab is being investigated in 1013 different clinical trials, with 124 of those in Phase 3. The majority of these studies are based out of Houston, Texas; however, there are a total of 36650 locations running Pembrolizumab trials."
Why did researchers design this clinical trial?
"The primary objective for this study, which will be measured over a 3-month period, is Event-Free Survival (EFS). Additionally, Seagen Inc. reports that the study will measure secondary outcomes including Disease-Free Survival (DFS), Overall Survival (OS), and Pathologic Complete Response Rate (pCRR)."
How many research participants are included in this investigation?
"In order to successfully carry out this research project, 857 eligible individuals are required. The pharmaceutical company Seagen Inc. will be administering the trial from multiple sites including Silverado Research Inc. ( Site 0111) located in Victoria, British Columbia and Moncton Hospital - Horizon Health Network ( Site 0112) situated in Moncton, New Brunswick."
How many hospitals are participating in this research project?
"Currently, this clinical trial is running in 19 locations. If you are interested enrolling, try to choose the location that is closest to you from the Victoria, Moncton, Aurora, and other 19 sites."
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