Study on Enfortumab Vedotin, Pembrolizumab, and Quemliclustat for Treating Advanced Urothelial Cancer

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT07667335

Provider View

This clinical trial is testing a new combination of drugs to treat advanced urothelial cancer that cannot be removed by surgery. The study aims to find the safest and most effective dose of quemliclustat when used with enfortumab vedotin and pembrolizumab.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced urothelial cancer, which affects the bladder, renal pelvis, or ureter and cannot be surgically removed. The treatment combines three drugs: enfortumab vedotin, pembrolizumab, and quemliclustat. Enfortumab vedotin targets cancer cells and delivers a drug to kill them, while pembrolizumab helps the immune system attack cancer. Quemliclustat may block enzymes needed for cancer cell growth. The study will assess the safety and effectiveness of this combination.

Description

In this study, participants will receive the following treatments:

  • Quemliclustat given through an IV on day 1 of each cycle.
  • Enfortumab vedotin given through an IV on days 1 and 8 of each cycle.
  • Pembrolizumab given through an IV on day 1 of each cycle.

Each treatment cycle lasts 21 days, and participants can continue for up to 2 years unless the cancer progresses or side effects become unacceptable. Participants may have a tumor biopsy before and during the study, and will undergo regular CT or MRI scans and blood tests to monitor their health.

After finishing the study treatment, participants will have follow-up visits within 30 days and then every 12 weeks for 3 years to check on their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and provide written consent to participate.
  • Have advanced bladder, renal pelvis, or ureter cancer that has not been treated before and cannot be removed by surgery.
  • Have a specific type of urothelial cancer confirmed by a specialist.
  • Have measurable cancer according to standard criteria.
  • Be in relatively good health with an ECOG performance status of 0-2.
  • Provide a tumor sample for research purposes.
  • Have a life expectancy of at least 3 months.
  • Meet specific blood count and organ function requirements, including:
    • Hemoglobin level of at least 9 g/dL.
    • Neutrophil count of at least 1500/µL.
    • White blood cell count of at least 3000/µL.
    • Lymphocyte count of at least 1000/µL.
    • Platelet count of at least 100,000/µL.
    • Liver enzymes and bilirubin levels within specified limits.
    • Kidney function within specified limits.
    • Normal blood clotting times.

Exclusion Criteria

  • Currently receiving other investigational treatments or anticancer therapies.
  • Have tumors with certain types of cell histology not allowed in the study.
  • Considered medically unfit for the treatment regimen.
  • Using systemic steroids within 10 days of starting the study, except for specific low-dose uses.
  • Experienced cancer progression after recent therapy.
  • Have a prolonged QT interval on an ECG.
  • Have active autoimmune diseases, except for certain controlled conditions.
  • Have HIV with a low CD4 count or active hepatitis B or C.
  • Have untreated or symptomatic brain metastases.
  • Have any condition that could interfere with the study or is not in the participant's best interest.
  • Women who are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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