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

Recruiting in Palo Alto (17 mi)

+193 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy \[gemcitabine plus cisplatin\] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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.

Inclusion Criteria

My organs are functioning well.

My bladder cancer has not spread beyond my pelvis.

I am considered a candidate for surgery to remove my bladder and nearby lymph nodes.

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Exclusion Criteria

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

I cannot receive cisplatin due to specific health reasons.

I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.

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Treatment Details

Interventions

Cisplatin (Alkylating agents)
Enfortumab vedotin (EV) (Antibody-Drug Conjugate)
Gemcitabine (Anti-metabolites)
Pembrolizumab (Monoclonal Antibodies)
Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND) (Surgery)

Trial OverviewThe 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.

Participant Groups

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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: