Study on Plasma Exchange with Enfortumab Vedotin and Pembrolizumab for Treating Bladder Cancers

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07087860

Provider View

This clinical trial is testing a new treatment approach for bladder and upper urinary tract cancers that have spread and not responded to previous treatments. It combines plasma exchange with two cancer drugs, enfortumab vedotin and pembrolizumab, to see if it works better than standard treatments.

Patient Parameters

Program Overview

This study is exploring whether a combination of therapeutic plasma exchange (TPE) with the drugs enfortumab vedotin and pembrolizumab can better treat bladder and upper urinary tract cancers that have spread and not responded to previous treatments. TPE is a process where blood is taken from the body, the plasma is separated and removed, and the remaining blood is returned. Enfortumab vedotin targets cancer cells and delivers a drug to kill them, while pembrolizumab helps the immune system attack cancer. The study aims to see if this combination is more effective than standard treatments.

Description

The main goal of this study is to compare how well patients with metastatic bladder cancer respond to a combination of therapeutic plasma exchange (TPE) and the drugs enfortumab vedotin and pembrolizumab, versus standard next-line treatments. Researchers will look at how many patients' cancers shrink or disappear, how long they live, and how long they stay free of cancer progression. They will also assess the safety of the treatments and the patients' quality of life.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will undergo TPE and receive enfortumab vedotin and pembrolizumab. They will have these treatments every 21 days unless the cancer progresses or side effects become unacceptable. Patients will also have regular scans and provide blood and urine samples.

  • Group B: Patients will receive the standard next-line treatment chosen by their doctor. They will also have regular scans and provide blood and urine samples.

After finishing the study treatment, patients will be followed up every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • Diagnosed with bladder or upper urinary tract cancer that has progressed despite previous treatment with enfortumab vedotin and pembrolizumab
  • Have measurable cancer according to specific criteria
  • Be in good overall health with a performance status score of 0, 1, or 2
  • Meet specific blood and organ function requirements
  • Not be pregnant and agree to use contraception if of childbearing potential
  • Willing to provide informed consent and participate in study procedures
  • Agree to provide blood, urine, and tissue samples for research
  • Willing to return for follow-up visits

Exclusion Criteria

  • Pregnant or breastfeeding individuals
  • Individuals not willing to use contraception if they can have children
  • Certain types of cancer cell features
  • Other active cancers requiring treatment within the last 24 months, except for specific cases like cured skin or cervical cancer
  • Uncontrolled heart disease or recent serious heart events
  • Any condition that the study doctor believes would not be in the participant's best interest or could interfere with the study

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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