Study on Circulating Tumor DNA Response in Urothelial Cancer

Sponsor: University of Oklahoma

Sponsor score: 40

ClinicalTrials ID:NCT07183319

Provider View

This clinical trial is testing the effectiveness of using pembrolizumab alone after 24 weeks of initial treatment with pembrolizumab and Enfortumab Vedotin in patients with metastatic urothelial cancer.

Patient Parameters

Program Overview

The aim of this study is to see if reducing the treatment to just pembrolizumab after 24 weeks can still effectively manage metastatic urothelial cancer. Patients will start with a combination of pembrolizumab and Enfortumab Vedotin. After 24 weeks, if their cancer is stable or improving and their tumor DNA levels have dropped by at least 50%, they will switch to pembrolizumab alone. If the cancer worsens or side effects increase during this phase, the original combination treatment will be resumed.

Description

This study is focused on patients with metastatic urothelial carcinoma (mUC) and aims to see if reducing the treatment to pembrolizumab alone after initial combination therapy is effective. Patients will first receive pembrolizumab and Enfortumab Vedotin as the standard treatment. After 24 weeks, their cancer will be evaluated. If the cancer is stable or improving and there is a significant reduction in tumor DNA levels, they will switch to pembrolizumab alone. If the cancer progresses or side effects become severe, the original combination treatment will be restarted.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic urothelial cancer that cannot be surgically removed.
  • Have measurable cancer according to specific medical criteria, even if they have had radiation therapy before.
  • Be eligible to receive certain chemotherapy drugs, as determined by the study doctor.
  • Have available tumor tissue samples for analysis.
  • Be in good overall health with a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood and organ function based on specific medical tests.

Exclusion Criteria

  • Have previously received Enfortumab Vedotin or similar drugs.
  • Have been treated with certain immune therapy drugs for any cancer within the last 12 months.
  • Have received other cancer treatments that are not allowed within 28 days before starting the study.
  • Have uncontrolled diabetes or severe nerve damage.
  • Have a life expectancy of less than 12 weeks.
  • Have untreated cancer that has spread to the brain.
  • Have ongoing significant side effects from previous treatments.
  • Are currently being treated for an active infection.
  • Have active hepatitis B, hepatitis C, or HIV.
  • Have had another invasive cancer requiring treatment within the last 3 years, except for certain skin or prostate cancers.
  • Have had a stroke, heart attack, or severe heart problems within the last 6 months.
  • Have received radiation therapy or major surgery within the last 2 weeks.
  • Have severe allergies to components of the study drugs.
  • Have active eye infections or ulcers.
  • Have a history of autoimmune disease requiring treatment in the last 2 years.
  • Have received a live vaccine within the last 30 days.

Locations

FACILITYZIPCITYSTATE
OU Health Stephenson Cancer Center73117Oklahoma CityOklahoma

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