What side effects are associated with this type of intervention?

Common treatments for urothelial carcinoma, particularly those involving immune checkpoint inhibitors like Pembrolizumab, can lead to a range of side effects. These include immune-related adverse events such as skin reactions (rash, pruritus), endocrine disorders (hypothyroidism, adrenal insufficiency), and gastrointestinal issues (diarrhea, colitis). Severe side effects can include pneumonitis, hepatitis, and nephritis. Combination therapies, such as those involving PD-1 and LAG-3 or TIGIT inhibitors, may increase the incidence and severity of these adverse events.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of metastatic urothelial carcinoma. It has shown efficacy both as a monotherapy and in combination with other agents. While specific combinations involving LAG-3 or TIGIT inhibitors like favezelimab or vibostolimab are still under investigation, pembrolizumab remains a cornerstone in the treatment landscape of urothelial carcinoma.

What other types of research exist?

Promising novel alternatives for urothelial carcinoma treatment in 2024 include: <ol> <li>Enfortumab Vedotin (EV) combined with immune checkpoint inhibitors like Pembrolizumab.</li> <li></li> </ol> Erdafitinib, a fibroblast growth factor receptor (FGFR) inhibitor, particularly for patients with FGFR genetic alterations. 3. Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2. 4. Atezolizumab, another PD-L1 inhibitor, either alone or in combination with other agents. 5. Novel combinations involving immune checkpoint inhibitors such as Nivolumab and Ipilimumab.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~4 years for reporting.

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 more

Secondary 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 more

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.

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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

3,950 Previous Clinical Trials

5,174,593 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,834 Previous Clinical Trials

8,079,390 Total Patients Enrolled

~260 spots leftby May 2027

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