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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 clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis

Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)

Must not have

Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder

Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ~12 months to up to ~68 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer treatment or been in a cancer study within the last 3 years.

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I cannot receive cisplatin due to specific health reasons.

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I have diabetes with an HbA1c level of 7% or higher and symptoms.

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I have had surgery to remove part of my bladder for cancer.

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I have an immunodeficiency or a known HIV, Hepatitis B, or active Hepatitis C infection.

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I have moderate to severe numbness, tingling, or muscle weakness.

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I have received an organ or tissue transplant from another person.

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I have an active eye infection or corneal ulcer.

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My cancer has spread to nearby lymph nodes or other parts of my body.

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I have had treatment for bladder cancer but not with specific immune therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ~12 months to up to ~68 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-Free Survival (EFS)

Secondary study objectives

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

Awards & Highlights

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.

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 3

~3150

0 / 14Eligibility criteria met