Actively Recruiting
Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers
Led by Mayo Clinic · Updated on 2026-05-08
70
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The plasma is then removed. The remaining blood components are combined with replacement fluid and returned to the patient's bloodstream through the intravenous or central line. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Treatment with enfortumab vedotin and pembrolizumab is already approved by the Food and Drug Administration for the treatment of bladder cancer, but TPE is not. Combining TPE with enfortumab vedotin and pembrolizumab may work better than standard of care options for treating metastatic and refractory bladder and urinary tract cancers. This study also evaluates the effect of TPE with standard of care antibody drug conjugates (ADCs) in treating patients with refractory metastatic bladder cancer. ADC therapy is treatment with a monoclonal antibody linked to a chemotherapy drug. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, and delivers chemotherapy to kill them. Giving TPE with standard of care ADC therapy may be effective in treating patients with refractory metastatic bladder cancer.
CONDITIONS
Official Title
Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed urothelial carcinoma of the bladder or upper urinary tract that progressed despite enfortumab vedotin and pembrolizumab (Groups A and B)
- Histologically confirmed urothelial carcinoma of the bladder or upper urinary tract that progressed despite antibody-drug conjugate therapy and not eligible for Groups A and B (Cohort C)
- Measurable disease by RECIST version 1.1
- ECOG performance status grade 0, 1, or 2
- Hemoglobin greater than 7.0 g/dL within 30 days before registration
- Platelet count at least 75,000/mm^3 within 30 days before registration
- ALT or AST less than or equal to 3.5 times the upper limit of normal, or total or direct bilirubin less than or equal to 3 times the upper limit of normal within 30 days before registration
- Estimated glomerular filtration rate (GFR) of at least 15 ml/min within 30 days before registration
- Negative pregnancy test within 8 days before registration for persons who can become pregnant
- Ability to provide written informed consent
- Ability to complete questionnaires independently or with help
- Willingness to undergo assigned treatment
- Willingness to provide mandatory blood, fluid, and tissue specimens for research
- Willingness to return to enrolling institution for follow-up during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child unwilling to use adequate contraception
- Presence of any neuroendocrine or signet ring cell features in tumor histology
- Active malignancies requiring treatment change within 24 months before registration, except for completely cured skin cancers, non-invasive cervical cancer, low-risk breast cancer in situ, or localized low-risk prostate cancer
- History of uncontrolled cardiovascular disease within 6 months before registration, including severe heart failure, unstable angina, arrhythmias, recent heart attack, ventricular fibrillation, cerebrovascular accident, or transient ischemic attack
- Psychiatric illness or social situations limiting compliance with study requirements
- Any condition that, in the investigator's opinion, would not be in the participant's best interest or would interfere with study assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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