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Enfortumab Vedotin + Pembrolizumab for Bladder Cancer (KEYNOTE-B15 Trial)
KEYNOTE-B15 Trial Summary
This trial is testing a new combination of drugs to treat bladder cancer that has spread to the lymph nodes. The new combination is enfortumab vedotin plus pembrolizumab, which will be given before surgery. The trial will compare this new combination to the standard of care, which is neoadjuvant chemotherapy with gemcitabine and cisplatin, followed by surgery. The trial will measure how well the new combination works by looking at the pathologic complete response rate and event free survival.
KEYNOTE-B15 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKEYNOTE-B15 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KEYNOTE-B15 Trial Design
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Who is running the clinical trial?
Media Library
- I have had cancer treatment or been in a cancer study within the last 3 years.My organs are functioning well.I cannot receive cisplatin due to specific health reasons.My bladder cancer has not spread beyond my pelvis.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.I have diabetes with an HbA1c level of 7% or higher and symptoms.I am considered a candidate for surgery to remove my bladder and nearby lymph nodes.I am fully active or restricted in physically strenuous activity but can do light work.My bladder cancer is mostly urothelial and confirmed by tissue analysis.I have had surgery to remove part of my bladder for cancer.I have not had a live vaccine in the last 30 days.I have an immunodeficiency or a known HIV, Hepatitis B, or active Hepatitis C infection.I have moderate to severe numbness, tingling, or muscle weakness.You have a diagnosed mental health condition or substance abuse issue.I have received an organ or tissue transplant from another person.I have an active eye infection or corneal ulcer.My cancer has spread to nearby lymph nodes or other parts of my body.I have had treatment for bladder cancer but not with specific immune therapies.
- Group 1: Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND
- Group 2: Arm A: Perioperative EV+ Pembrolizumab and RC + PLND
- 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
Are there open positions in this trial for prospective participants?
"From what is detailed on clinicaltrials.gov, it appears as though this study is still in the process of recruiting patients. The listing was first posted on April 21st, 2021 and was last edited on October 21st, 2022."
What type of cancer does Cisplatin commonly target?
"Cisplatin is a chemotherapy medication commonly used to treat refractory, relapsed mediastinal large b-cell lymphoma. Cisplatin can also be administered to patients with small cell lung cancer, advanced testicular cancer, and urinary bladder cancer."
Can you provide a comprehensive list of all Cisplatin clinical trials to date?
"City of Hope Comprehensive Cancer Center published the first study on cisplatin in 1997. Since then, there have been a total of 1834 completed studies with 1905 active trials. Many of these are located in Houston, Texas."
Are there several hospitals running this clinical trial in different parts of the world?
"Patients can be seen at Houston Methodist Urology Associates (Site 0033) in Houston, Texas, St. Joseph Heritage Healthcare (Site 0035) in Fullerton, California, Mayo Clinic in Arizona - Phoenix (Site 0043) in Phoenix, Arizona, and 25 other locations."
Why was this clinical trial undertaken?
"The primary outcome of this trial is Pathologic Complete Response (pCR) Rate, which will be measured over a Up to approximately 5 years time frame. Secondary outcomes include Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) and Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)."
Are there any adverse effects to Cisplatin?
"Cisplatin has been found to be effective in prior clinical trials and has thus been rated a 3 for safety."
Are there a limited number of spots available for this research project?
"That is correct, the clinicaltrials.gov website has updated information that this study is still looking for 784 participants from 25 different locations. The study was first posted on 4/21/2021 and was edited on 10/21/2022."
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