Actively Recruiting
MC220503 Randomized Phase II Rescuing Cancer Immunotherapy With Plasma Exchange in Bladder Cancer 1 (ReCIPE-B1)
Led by Mayo Clinic · Updated on 2026-05-08
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating therapeutic plasma exchange (TPE) combined with enfortumab vedotin and pembrolizumab compared to standard next-line therapies for patients with metastatic bladder or upper urinary tract cancers that have not responded to previous treatments. This phase II trial also assesses TPE with standard antibody drug conjugates (ADCs) in treating refractory metastatic bladder cancer. The study aims to compare response rates, survival outcomes, safety, and quality of life between these treatments. Participants are assigned to one of three groups. Group A receives TPE on days 1-3 of cycles 1-3, enfortumab vedotin intravenously on days 3 and 10 of cycles 1-3 and days 1 and 8 thereafter, and pembrolizumab on day 3 of cycles 1-3 and day 1 thereafter. Group B receives physician's choice of standard next-line therapy. Cohort C receives TPE on days 1-3 of cycles 1-3 and standard ADC therapy intravenously on day 3 of cycles 1-3 and day 1 thereafter. Treatment cycles repeat every 21 days unless disease progresses or toxicity occurs. Participants undergo imaging scans such as CT, PET/CT, or MRI and provide blood and urine samples throughout the study. Quality of life is assessed at baseline and every 12 weeks. After treatment completion, patients are followed every 6 months for up to 5 years. The study monitors overall response rate, duration of response, progression-free survival, overall survival, safety, and quality of life to evaluate the impact of these therapies.
CONDITIONS
Brief 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 has progressed despite prior treatment with enfortumab vedotin and pembrolizumab (Groups A and B) or antibody drug conjugate therapy (Cohort C)
- Measurable disease according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Hemoglobin greater than 7.0 g/dL within 30 days prior to registration
- Platelet count at least 75,000/mm3 within 30 days prior to registration
- Liver enzyme levels (ALT or AST) no greater than 3.5 times upper limit of normal or bilirubin levels no greater than 3 times upper limit of normal within 30 days prior to registration
- Estimated glomerular filtration rate (GFR) at least 15 ml/min within 30 days prior to registration
- Negative pregnancy test within 8 days prior to registration for persons of childbearing potential
- Ability to provide written informed consent
- Ability to complete questionnaires independently or with assistance
- Willingness to undergo assigned treatment and provide mandatory blood, urine, and tissue samples for research
- Willingness to return for follow-up visits during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or who can father a child and are unwilling to use adequate contraception
- Presence of any neuroendocrine or signet ring cell features in tumor tissue
- Active malignancies other than the cancer being treated, except for certain cured skin, cervical, breast, or prostate cancers
- History of uncontrolled cardiovascular disease within 6 months prior to registration, including severe heart failure, unstable angina, arrhythmias, recent heart attack, or stroke
- Psychiatric illness or social situations that would limit compliance with study requirements
- Any condition that, in the investigator's opinion, would compromise participant well-being or interfere with study assessments
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive treatment according to their assigned group: Group A receives therapeutic plasma exchange on days 1-3 of cycles 1-3, enfortumab vedotin IV, and pembrolizumab IV in repeated 21-day cycles; Group B receives physician's choice of next-line standard of care therapy; Cohort C receives therapeutic plasma exchange on days 1-3 of cycles 1-3 and physician's choice of standard of care antibody-drug conjugate therapy IV. Imaging and collection of blood and urine samples occur throughout treatment.
Multiple visits every cycle for treatment and assessments
Duration - Up to 5 years
After completion of treatment, participants are followed every 6 months for up to 5 years for survival, disease progression, safety monitoring, and quality of life assessments.
Visits every 6 months for up to 5 years
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
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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