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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 belowSelect...
My cancer in the urinary system is confirmed and cannot be surgically removed.
Select...
I can provide a sample of my tumor that has not been treated with radiation.
Select...
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
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.I have another cancer besides bladder cancer that needed treatment in the last 3 years.I have not received a live vaccine within the last 30 days.I can provide a sample of my tumor that has not been treated with radiation.I am currently on medication for an infection.I have a history of hepatitis B or C.My cancer in the urinary system is confirmed and cannot be surgically removed.I haven't had cancer treatment or been in a trial for at least 4 weeks.My cancer progressed or came back despite PD-1/L1 treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Zilovertamab vedotin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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