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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

Study Summary

This trial will study the efficacy and safety of drugs given with pembrolizumab to treat advanced melanoma. Part 2 could be considered if results show improved outcomes.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,888 Previous Clinical Trials

5,054,693 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,498 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals are this clinical trial attempting to accomplish?

"This medical trial will monitor patient outcomes for up to 4 years and the primary endpoint is assessing adverse events. Other measurements, such as mean changes from baseline in physical functioning (using a 0-100 scale) or time to deterioration of EQ-5D-5L VAS scores and EORTC QLC-C30 physical functioning scales, are also being recorded as secondary endpoints."

Answered by AI

What is the cap on patient recruitment for this clinical experiment?

"This clinical trial requires 390 volunteers who meet the stipulated inclusion criteria. Participants can seek treatment at several sites, such as Austin Health-Cancer Clinical Trials Centre in Heidelberg (Site 3950) and FALP-UIDO in Santiago ( Site 3151)."

Answered by AI

Is there still availability to join this medical trial?

"According to the clinicaltrials.gov website, this medical study is actively recruiting participants; it was first issued on June 23rd and most recently revised on August 14th of this year."

Answered by AI

How geographically dispersed is this experiment?

"The trial for this investigation is running at 13 medical sites, including Heidelberg, Santiago and Antofagasta. To reduce travel complications, it is beneficial to choose the closest site when enrolling in this experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)

2023. "A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05845814.