Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
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 people with muscle invasive bladder cancer
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 had certain treatments, surgical procedures or drugs.
- You have certain types of non-cancer medical conditions.
- You have been diagnosed with a prior or secondary type of cancer.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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)
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