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Alkylating agents

Enfortumab Vedotin + Pembrolizumab for Bladder Cancer (KEYNOTE-B15 Trial)

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have adequate organ function
Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from ~12 months to up to ~68 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with muscle invasive bladder cancer (MIBC) that's not spread beyond the lymph nodes. They must have mostly urothelial cancer, be fit for surgery to remove the bladder and nearby lymph nodes, and have good organ function. People can't join if they've had certain cancers or treatments in the last 3 years, live vaccines recently, HIV/Hepatitis B/C infections, severe neuropathy or eye issues, uncontrolled diabetes, are ineligible for cisplatin chemotherapy or have more advanced cancer.Check my eligibility
What is being tested?
The study compares two approaches before and after bladder removal surgery: one group gets a drug combo of Enfortumab Vedotin plus Pembrolizumab; another receives standard chemo with Gemcitabine plus Cisplatin. The goal is to see which method keeps patients free from cancer events longer.See study design
What are the potential side effects?
Enfortumab Vedotin may cause skin reactions, high blood sugar levels, kidney problems and peripheral neuropathy. Pembrolizumab might lead to immune system-related side effects affecting various organs. Standard chemo could result in nausea, low blood cell counts leading to infection risk or bleeding problems.

KEYNOTE-B15 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs are functioning well.
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My bladder cancer has not spread beyond my pelvis.
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I am considered a candidate for surgery to remove my bladder and nearby lymph nodes.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My bladder cancer is mostly urothelial and confirmed by tissue analysis.

KEYNOTE-B15 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from ~12 months to up to ~68 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from ~12 months to up to ~68 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-Free Survival (EFS)
Secondary outcome measures
Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score (Items 6-7)
+9 more

KEYNOTE-B15 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Perioperative EV+ Pembrolizumab and RC + PLNDExperimental Treatment3 Interventions
Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.
Group II: Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLNDActive Control3 Interventions
Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,127 Total Patients Enrolled
Astellas Pharma IncIndustry Sponsor
689 Previous Clinical Trials
219,255 Total Patients Enrolled
Seagen Inc.Industry Sponsor
206 Previous Clinical Trials
68,555 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04700124 — Phase 3
Bladder Cancer Research Study Groups: Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND, Arm A: Perioperative EV+ Pembrolizumab and RC + PLND
Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04700124 — Phase 3
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04700124 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~369 spots leftby Dec 2026