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Antibody-drug Conjugate
Pembrolizumab + Enfortumab Vedotin for Urothelial Carcinoma
Phase 2
Waitlist Available
Led By Karim Chamie
Research Sponsored by Jonsson Comprehensive Cancer Center
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 3 years
Awards & highlights
Study Summary
This trial tests a new immunotherapy/drug combo for high-risk upper tract urothelial cancer before and after surgery.
Who is the study for?
Adults with high-risk upper tract urothelial cancer can join this trial. They must have proper kidney function, normal blood counts, and be in good physical condition (ECOG 0-1). Women should not be pregnant or breastfeeding and must follow contraceptive guidance. Men also need to use contraception. Participants cannot have had certain treatments recently, other active cancers, severe allergies to the drugs being tested, or any immune system problems.Check my eligibility
What is being tested?
The trial is testing if combining pembrolizumab (an immunotherapy drug) with enfortumab vedotin (a targeted therapy) before and after surgical removal of a kidney and ureter can better treat patients. Pembrolizumab boosts the immune system's response against cancer cells while enfortumab vedotin delivers a toxin directly to them.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, fatigue from treatment-related anemia, liver enzyme changes due to drug toxicity, increased risk of infection from white blood cell count drops, bleeding issues related to low platelets count, and potential impact on organ functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological objective response (ORR) rate
Radiographic recurrence-free survival
Secondary outcome measures
Incidence of adverse events
Perioperative complications
Rates of completion of neoadjuvant pembrolizumab and enfortumab vedotin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, enfortumab vedotin)Experimental Treatment6 Interventions
Patients receive pembrolizumab IV and enfortumab vedotin IV on study. Patients undergo radical nephroureterectomy and receive pembrolizumab IV on study Patients also undergo MRU imaging and undergo blood, urine and tissue sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1730
Nephroureterectomy
2015
Completed Phase 2
~40
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,029 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,953 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,136 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of Hepatitis B or active Hepatitis C.I have not received a live vaccine in the last 30 days.I don't have any health issues that could affect the study's results.I have received treatment with specific drugs before.I have another cancer that is getting worse or was treated in the last 2 years.I have an immune system disorder or have been on steroids recently.I haven't had cancer treatment in the last 4 weeks.I have an active eye infection or corneal ulcer.I am 18 or older with a confirmed high-risk upper tract urothelial carcinoma diagnosis.I can provide a sample of my tumor, either from previous or new biopsy.I have received an organ or tissue transplant from another person.I am not pregnant, not breastfeeding, and follow birth control guidelines.I can carry out all my usual activities without help.I had radiotherapy less than 2 weeks before starting the study treatment.I have received specific treatments before.I have been diagnosed with HIV.I have had or currently have lung inflammation treated with steroids.I have active brain metastases or cancer in the lining of my brain.I agree to use contraception and not donate sperm for 6 months after my last treatment dose.I am currently on medication for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, enfortumab 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 endeavor presently inviting participants to take part?
"This research project, which was posted on May 1st 2023 and updated lastly on March 15th 2023, is not currently in search of participants. However, 2540 other clinical trials are actively engaging patients at this time."
Answered by AI
Is the combination of pembrolizumab and enfortumab vedotin safe for human consumption?
"Our team judged the risk associated with Treatment (pembrolizumab, enfortumab vedotin) to be 2 on a scale of 1-3. This is because it's only gone through Phase 2 trials and safety has been documented though efficacy remains unproven."
Answered by AI
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