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Antibody-drug conjugate

Zilovertamab Vedotin 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

Histologically or cytologically confirmed diagnosis of locally advanced/unresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra

Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Study Summary

This trial will evaluate new treatments for people with urothelial carcinoma that hasn't responded to PD-1/L1 inhibitors. It will assign investigational treatments to participants.

Who is the study for?

This trial is for adults with advanced bladder cancer that hasn't responded to PD-1/L1 inhibitors. They must have a confirmed diagnosis and provide a tumor tissue sample. People can't join if they've had recent cancer treatment, active infections needing systemic therapy, live vaccines within 30 days, or HIV/hepatitis B/C.Check my eligibility

What is being tested?

The study tests Zilovertamab vedotin in patients with urothelial carcinoma resistant to PD-1/L1 blockers. It's part of a larger study exploring new treatments alongside pembrolizumab, assigning them as options become available.See study design

What are the potential side effects?

While specific side effects for Zilovertamab vedotin aren't listed here, similar drugs often cause fatigue, nausea, hair loss, lowered blood cell counts increasing infection risk, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer in the urinary system is confirmed and cannot be surgically removed.

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I can provide a sample of my tumor that has not been treated with radiation.

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My cancer progressed or came back despite PD-1/L1 treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 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

Objective Response Rate (ORR)

Percentage of Participants Who Discontinued Study Treatment Due to an AE

Percentage of Participants Who Experienced At Least One Adverse Event (AE)

Secondary outcome measures

Duration of Response (DOR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zilovertamab vedotinExperimental Treatment1 Intervention

Participants will receive zilovertamab vedotin 2mg/kg administered on Day 1 and Day 8 of each 3 week cycle (Q3W) until documented disease progression or any other discontinuation criterion is met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zilovertamab vedotin

2019

Completed Phase 2

~200

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,531 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,440 Total Patients Enrolled

Media Library

Zilovertamab vedotin (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05562830 — Phase 1 & 2

Bladder Cancer Research Study Groups: Zilovertamab vedotin

Bladder Cancer Clinical Trial 2023: Zilovertamab vedotin Highlights & Side Effects. Trial Name: NCT05562830 — Phase 1 & 2

Zilovertamab vedotin (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562830 — Phase 1 & 2

Frequently Asked Questions

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

Is this research project actively seeking participants?

"Correct. Per the clinicaltrials.gov post, this research trial is currently recruiting participants - it was initially published on November 16th 2022 and has had its information updated as recently as January 25th 2023."

Answered by AI

How many participants have the capacity to join this experiment?

"Affirmative, records on clinicaltrials.gov reveal that recruitment for this medical experiment is ongoing. The trial was initially posted on November 16th 2022 and last updated January 25th 2023; the research seeks to enroll 40 people in a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

2022. "A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05562830.