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Therapeutic Plasma Exchange with Enfortumab Vedotin and Pembrolizumab for Bladder Cancers

This study is for people with bladder or upper urinary tract cancer that has spread (metastatic) and has not responded to previous treatments like enfortumab vedotin and pembrolizumab. It compares a treatment called therapeutic plasma exchange (TPE) followed by enfortumab vedotin and pembrolizumab to standard next-line therapy. TPE is a procedure where your blood is slowly removed, plasma (the liquid part of blood) is separated out, and then the rest of your blood is returned. The study aims to see if this approach improves how well the cancer responds to treatment. You may be eligible if you are at least 18 years old and your cancer has progressed despite prior enfortumab vedotin and pembrolizumab treatment. The study plans to enroll 70 participants.

Study design
This is an interventional study comparing therapeutic plasma exchange with enfortumab vedotin and pembrolizumab to standard care for metastatic bladder cancer. It aims to enroll 70 participants.
What's involved
You would undergo collection of blood and urine samples, potentially have a central venous cannula inserted, and receive CT or PET/CT scans. The specific frequency and duration of these procedures are not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, overall response rate, is measured up to 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07087860

Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~70 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Best PracticeBiospecimen CollectionCentral Venous Cannula InsertionComputed TomographyEnfortumab VedotinMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR) (Groups A and B)
Measured over Up to 6 months
+1 more outcome measured

Conditions

Metastatic Bladder Urothelial Carcinoma
Metastatic Renal Pelvis and Ureter Urothelial Carcinoma
Refractory Bladder Urothelial Carcinoma
Refractory Renal Pelvis and Ureter Urothelial Carcinoma
Stage IV Bladder Cancer AJCC v7
Stage IV Renal Pelvis and Ureter Cancer AJCC v7

Explore related trials

Urothelial Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Jacob J. Orme, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overall response rate (ORR) (Groups A and B)Up to 6 months

    ORR is defined as proportion of evaluable patients with complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  • ORR (Cohort C)Up to 6 months

    ORR is defined as proportion of evaluable patients with complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.