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NCT07087860 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Renal Pelvis and Ureter Urothelial Carcinoma, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 2
Development phase
70
Enrollment target
1
Study location

NCT07087860 is a Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Renal Pelvis and Ureter Urothelial Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 70 participants, below the 120-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07087860, a Phase 2 study of Metastatic Bladder Urothelial Carcinoma and Metastatic Renal Pelvis and Ureter Urothelial Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

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

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Enfortumab Vedotin
  • OTHER Best Practice
  • PROCEDURE Central Venous Cannula Insertion

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2025-08-01
Est. Completion 2028-08-07
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07087860

The ClinicalTrials.gov registry entry for NCT07087860 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 120-participant average among 13 other Metastatic Bladder Urothelial Carcinoma trials with a reported enrollment target (42% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Metastatic Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT07087860 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT07087860 about?

NCT07087860 is a clinical study titled "Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers". 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 t...

What is the current status of trial NCT07087860?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2025-08-01. Estimated completion is 2028-08-07.

What conditions does trial NCT07087860 study?

This clinical trial studies the following conditions: Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v7, Refractory Bladder Urothelial Carcinoma, Refractory Renal Pelvis and Ureter Urothelial Carcinoma.

What interventions are being tested in trial NCT07087860?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Enfortumab Vedotin (DRUG), Best Practice (OTHER), Central Venous Cannula Insertion (PROCEDURE).

Who is sponsoring clinical trial NCT07087860?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07087860 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.