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Antibody-Drug Conjugate
Pembrolizumab + EV for Bladder Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing new drug combinations to see if they work better than the current standard treatment for cancer patients. It focuses on patients treated with pembrolizumab plus EV. Pembrolizumab has shown effectiveness in various cancers, providing long-lasting responses and representing a major advancement in treatment options. The drugs aim to enhance the immune system's ability to fight cancer.
Who is the study for?
This trial is for adults with advanced bladder cancer that hasn't spread to the brain, who haven't had systemic therapy for it. They can have some other cancer types if they've been clear of them for 3+ years. No recent vaccines or investigational drugs, no immune diseases needing treatment in the last 2 years, and no active infections.
What is being tested?
The study tests how safe and effective new drug combos are: favezelimab/pembrolizumab plus EV, vibostolimab/pembrolizumab plus EV compared to just pembrolizumab plus EV. It's a two-part study where part one finds out which combo works best without comparing them directly.
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, skin rash, potential increase in risk of infection due to immune system suppression by the drugs being tested.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Objective Response Rate (ORR)
Part 1: Percentage of Participants experiencing an Adverse Event (AE)
Part 1: Percentage of Participants who Discontinue study interventions due to an AE
+2 moreSecondary study objectives
Part 1: Duration of Response (DOR)
Part 1: Mean Change from Baseline in the European Quality of Life 5 Dimensions, 5-level Questionnaire (EQ-5D-5L) visual analog score (VAS)
Part 1: Mean Change from baseline in the global health status/quality of life of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLC-C30) (Items 29 and 30)
+17 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Coformulated vibostolimab/pembrolizumab plus EVExperimental Treatment2 Interventions
Participants will receive coformulated vibostolimab/pembrolizumab (200 mg/200 mg) as an IV infusion on Day 1 of every 3-week cycle, for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.
Group II: Arm A: Coformulated favezelimab/pembrolizumab plus EVExperimental Treatment2 Interventions
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) as an intravenous (IV) infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.
Group III: Arm C: Pembrolizumab plus EVActive Control2 Interventions
Participants will receive 200 mg pembrolizumab as an IV infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle, until disease progression, intolerable toxicity, or investigator decision.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Urothelial Carcinoma include immune checkpoint inhibitors such as Pembrolizumab, which targets the PD-1 pathway. This pathway normally acts as a brake on the immune system, preventing it from attacking cancer cells.
By inhibiting PD-1, Pembrolizumab allows the immune system to recognize and destroy cancer cells more effectively. Additionally, combination therapies involving LAG-3 inhibitors (like Favezelimab) and TIGIT inhibitors (like Vibostolimab) are being studied.
These inhibitors target other immune checkpoints that cancer cells exploit to evade the immune system. By blocking these pathways, the combination therapies aim to enhance the immune response against cancer cells.
This is particularly important for Urothelial Carcinoma patients as it offers a potential for more effective and durable responses compared to traditional treatments.
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,985 Previous Clinical Trials
5,178,311 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,868 Previous Clinical Trials
8,082,240 Total Patients Enrolled
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