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Closed (no longer recruiting)Last updated: 20 December 2023

KEYNOTE-B15: This study is testing whether a new combination of anti-cancer drugs work more effectively than the current standard treatment with chemotherapy when given in addition to surgery in people with muscle invasive bladder cancerA Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm.

In the Experimental Arm, participants will receive 4 cycles (each lasting 21 days) of an antibody-drug conjugate (enfortumab vedotin [EV]) plus immunotherapy (pembrolizumab). EV will be given via intravenous infusion (IV) at a dose of 1.25mg on Day 1 and Day 8 every 3 weeks, and pembrolizumab will be given at a dose of 200mg via IV on Day 1 every 3 weeks. This will then be followed by a surgical procedure consisting of a radical cystectomy and a pelvic lymph node dissection. Following this, participants will receive 5 cycles of EV via IV infusion plus 13 cycles of pembrolizumab via IV. The total treatment duration for this arm is up to approximately 1 year.

In the Active Comparator Arm, participants will receive 4 cycles of standard of care chemotherapy (gemcitabine 1000mg/m^2 on day 1 and Day 8 every 3 weeks via IV infusion, plus cisplatin 70mg/m^2 on Day 1 every 3 weeks via IV infusion). This will then be followed by a radical cystectomy and a pelvic lymph node dissection. The total treatment duration for this arm is up to approximately 3 months.

Conditions

This trial is treating patients with muscle invasive bladder cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

KEYNOTE-B15

More information

Trial Identifiers

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Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

Eligibility

Inclusion

  • Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
  • 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)
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate organ function.

Exclusion

  • Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
  • Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
  • Has ≥N2 disease or metastatic disease (M1) as identified by imaging
  • Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
  • Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
  • Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
  • Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection
  • Has a known psychiatric or substance abuse disorder
  • Has had an allogenic tissue/solid organ transplant
  • Has ongoing sensory or motor neuropathy Grade 2 or higher
  • Has active keratitis (superficial punctate keratitis) or corneal ulcerations
  • Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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