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Chemotherapy
Disitamab Vedotin + Pembrolizumab vs Chemotherapy for Bladder Cancer
Phase 3
Recruiting
Research Sponsored by Seagen Inc.
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 through 2 years after last study treatment; approximately 4 years
Awards & highlights
Study Summary
This trial will compare two treatments for advanced or metastatic urothelial cancer. One involves drugs disitamab vedotin and pembrolizumab, the other is chemotherapy. Side effects will be monitored.
Who is the study for?
This trial is for adults with advanced urothelial cancer, which includes bladder and kidney cancers. Participants must have measurable disease, be able to receive platinum-based chemo, express a certain level of HER2 protein, and not have had prior systemic therapy for their advanced cancer (with some exceptions). They should also be in a condition that allows daily activities with only slight limitations.Check my eligibility
What is being tested?
The study compares the effectiveness of disitamab vedotin combined with pembrolizumab versus standard chemotherapy (gemcitabine with cisplatin or carboplatin) in treating urothelial cancer. Patients are randomly placed into two groups: one receiving the new drug combination and the other receiving traditional chemotherapy.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, fatigue, nausea, lowered blood cell counts increasing infection risk, potential liver or lung inflammation from pembrolizumab; plus typical chemo side effects like hair loss and kidney issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 2 years after last study treatment; approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 2 years after last study treatment; approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
Secondary outcome measures
Change from baseline of left ventricular ejection fraction (LVEF)
Change from baseline to Week 16 in European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score
Control Rate (DCR) per RECIST v1.1 by BICR
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Disitamab vedotin armExperimental Treatment2 Interventions
disitamab vedotin + pembrolizumab
Group II: Standard of care armActive Control3 Interventions
gemcitabine + cisplatin OR carboplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,446 Total Patients Enrolled
RemeGen Co., Ltd.Industry Sponsor
74 Previous Clinical Trials
9,360 Total Patients Enrolled
Seagen Inc.Lead Sponsor
208 Previous Clinical Trials
73,528 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had systemic therapy for my bladder cancer, except if it came back 12+ months after initial treatment.I can be treated with cisplatin or carboplatin chemotherapy.I can provide a tissue sample from my cancer for testing.I have fluid buildup causing symptoms or needing treatment.My cancer has spread to my brain or its coverings but has been treated.I have an autoimmune disease that needed treatment in the last 2 years.I am allergic to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab.I have never had a severe reaction to immune therapy.My cancer shows some level of HER2 protein.I have had a solid organ or bone marrow transplant.My cancer is advanced and started in my urinary system.I have previously received treatments targeting immune system receptors.I can care for myself and am up and about more than 50% of my waking hours.I have previously been treated with an MMAE agent or anti-HER2 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Disitamab vedotin arm
- Group 2: Standard of care arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Disitamab vedotin been given the green light by the FDA?
"Disitamab vedotin arm has been assessed with a score of 3, indicating that there is prior clinical data to support its safety profile as it is currently in Phase 3 trials."
Answered by AI
What is the overall sample size of this research study?
"This is correct. According to clinicaltrials.gov, this medical investigation was first posted on August 31st 2023 and has since been actively recruiting patients across a single site. A total of 700 individuals are required for the trial's completion."
Answered by AI
Is enrollment for this clinical experiment still available?
"That is accurate. According to information from clinicaltrials.gov, this clinical trial was first published on August 31st 2023 and has since been recruiting participants at a single medical center for up to 700 patients in total."
Answered by AI
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