Study on Enfortumab Vedotin and Pembrolizumab with Surgery for Advanced Bladder and Upper Urothelial Tract Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06764095

Provider View

This clinical trial is exploring the effects of combining two drugs, enfortumab vedotin and pembrolizumab, with surgery to remove part or all of the bladder or ureter in patients with advanced bladder and upper urothelial tract cancer.

Patient Parameters

Program Overview

The study aims to see if using enfortumab vedotin and pembrolizumab, followed by surgery to remove part or all of the bladder (cystectomy) or ureter (ureterectomy), can improve outcomes for patients with bladder and upper urothelial tract cancer that has spread locally or to other parts of the body. Enfortumab vedotin is a drug that targets cancer cells, while pembrolizumab helps the immune system attack cancer. The combination may help slow or stop cancer growth and improve patient outcomes.

Description

The main goal of this study is to evaluate how well patients do without their cancer getting worse for 12 months after receiving enfortumab vedotin and pembrolizumab, followed by surgery. Researchers will also look at how many patients respond to the treatment, how many can undergo surgery, and how long patients live overall. They will also assess the safety of the treatment and any side effects.

Patients will receive enfortumab vedotin and pembrolizumab through an IV every three weeks for at least four cycles, as long as the cancer does not progress or side effects are manageable. If patients are suitable for surgery, they may have part or all of their bladder or ureter removed. After surgery, patients may continue receiving the drugs as maintenance therapy. Throughout the study, patients will have regular urine and blood tests, as well as imaging scans like CT, PET/CT, or MRI.

After completing the study treatment, patients will have follow-up visits every 12 weeks for up to five years to monitor their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of bladder or upper urothelial tract cancer that has spread locally or to other parts of the body.
  • Be willing to undergo surgery to remove part or all of the bladder or ureter if deemed suitable by a doctor.
  • Have a good overall health status, with an ECOG performance status of 0, 1, or 2.
  • Meet specific blood count and organ function requirements based on recent tests.
  • Have not received chemotherapy for bladder cancer in the past two years.
  • Be willing to provide blood and tissue samples for research purposes.
  • Be able to complete questionnaires and attend follow-up visits.
  • Agree to use effective contraception if of childbearing potential.

Exclusion Criteria

  • Have certain types of bladder cancer with specific histologic features.
  • Have received chemotherapy for bladder cancer in the past.
  • Have other active cancers requiring treatment in the past 24 months, except for certain skin, cervical, or prostate cancers.
  • Have uncontrolled heart disease or other serious medical conditions.
  • Have active infections like tuberculosis or hepatitis.
  • Have had an organ transplant or have active autoimmune diseases requiring treatment.
  • Be pregnant or breastfeeding.
  • Have received certain vaccines or treatments recently that could interfere with the study.
  • Have a history of severe allergic reactions to similar drugs.
  • Be unable to comply with study requirements or attend follow-up visits.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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