Blood 'Cleansing' may revive bladder cancer treatment
NCT ID NCT07087860
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a procedure that filters a patient's blood (therapeutic plasma exchange) can help standard cancer drugs work better in people with advanced bladder or urinary tract cancer that has stopped responding to previous treatments. About 70 adults will be randomly assigned to receive either the blood-filtering procedure plus two approved drugs (enfortumab vedotin and pembrolizumab) or the usual next-line therapy. The goal is to see if this combination can shrink tumors or slow cancer growth.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * GROPUS A and B (reCIPE-B1): Histologically proven urothelial carcinoma \[American Joint Committee on Cancer (AJCC) 2017\] of the bladder (BCa) or upper urothelial tract (UTUC), that has progressed despite enfortumab vedotin and pembrolizumab treatment * NOTE: Primary or secondary progression are allowed, therapies are not required to be concurrent or immediately antecedent to enrollment) * COHORT C (CAKE ReCIPE): Histologically proven urothelial carcinoma (AJCC 2017) of the bladder (BCa) or upper urothelial tract (UTUC), that has progressed despite ADC AND is otherwise not a candidate for Groups A and B * NOTE: Patients in Groups A and B who have progressed on that treatment are candidates for this cohort. Such patients must be re-consented and re- enrolled * Measurable disease per RECIST version (v)1.1 * Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1, or 2 * Hemoglobin \> 7.0 g/dL (obtained ≤ 30 days prior to registration) * Platelet count ≥ 75,000/mm\^3 (obtained ≤ 30 days prior to registration) * Alanine aminotransferase (ALT) OR aspartate transaminase (AST) ≤ 3.5 x upper limit of normal (ULN) OR total bilirubin ≤ 3 x ULN OR direct bilirubin ≤ 3 x ULN (obtained ≤ 30 days prior to registration) * Estimated glomerular filtration rate (GFR) ≥ 15 ml/min (obtained ≤ 30 days prior to registration) * Negative pregnancy test ≤ 8 days prior to registration, for persons of childbearing potential only * Provide written informed consent * Ability to complete questionnaire(s) by themselves or with assistance * Willingness to undergo treatment as assigned (group A: TPE + EV/pembro; OR group B: next line standard of care; OR Cohort C TPE + ADC) * Willingness to provide mandatory blood and fluid specimens for correlative research * Willingness to provide tissue specimens for correlative research * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) Exclusion Criteria: * Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown * Pregnant persons * Nursing persons * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception * Any of the following histologic variants/divergent differentiation: Any amount of neuroendocrine or signet ring cell features * Active malignancies (i.e., progressing or requiring treatment change ≤ 24 months before registration) other than the disease being treated under study * EXCEPTIONS: * Skin cancer (melanoma or non-melanoma) that is considered completely cured * Non-invasive cervical cancer that is considered completely cured * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ considered to have a very low risk of recurrence * Localized prostate cancer (T1c/T2N0M0): * Gleason score 6, treated by either surgery or ablation ≤ 24 months prior to registration or untreated and under active surveillance * Gleason score 3+4 that has been treated (may include surgery or ablation) ≤ 24 months prior to registration and considered to have a very low risk of recurrence (i.e., cT1c or pT2 on prostatectomy specimen) * History of uncontrolled cardiovascular disease including any of the following ≤ 6 months prior to registration: * Significant cardiovascular disease \[New York Heart Association (NYHA) class ≥ III\], symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, ventricular fibrillation, Torsades de Pointes, cerebrovascular accident, or transient ischemic attack * Psychiatric illness/social situations (e.g., substance abuse) that would limit compliance with study requirements * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participants (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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