Study on Pembrolizumab Maintenance After Initial Treatment with Enfortumab Vedotin and Pembrolizumab for Metastatic Urothelial Cancer

Sponsor: Fox Chase Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07221942

Provider View

This clinical trial is testing a treatment plan for patients with metastatic urothelial cancer, starting with a combination of enfortumab vedotin and pembrolizumab, followed by ongoing pembrolizumab therapy. The study aims to see if this approach can effectively manage the cancer.

Patient Parameters

Program Overview

This study is exploring a treatment for patients with metastatic urothelial carcinoma (a type of bladder cancer that has spread) who have not received prior treatment for their metastatic disease. The treatment begins with a combination of two drugs, enfortumab vedotin and pembrolizumab, for 18 weeks. If the cancer responds well, patients will continue with pembrolizumab alone for up to two years. The study will involve about 97 participants and aims to determine if this treatment plan can effectively control the cancer.

Description

The trial is designed to test a treatment plan for patients with metastatic urothelial carcinoma, which is a type of bladder cancer that has spread to other parts of the body. The study involves two main phases:

Induction Phase (18 weeks):

  • Patients will receive a combination of enfortumab vedotin and pembrolizumab for 18 weeks, which is divided into 6 cycles. Each cycle lasts 21 days.
  • Enfortumab vedotin is given on Days 1 and 8 of each cycle, and pembrolizumab is given on Day 1.
  • After 3 cycles (about 9 weeks), doctors will check how the cancer is responding. If the cancer is shrinking or stable, patients will continue with 3 more cycles.
  • After 6 cycles (about 18 weeks), if the cancer is still responding, patients will move to the next phase.

Maintenance Phase:

  • Patients whose cancer has responded will continue with pembrolizumab alone, either every 6 weeks or every 3 weeks, for up to 2 years.
  • Regular scans will be done every 12 weeks to monitor the cancer.
  • Treatment will continue until the cancer progresses, side effects become too severe, or the 2-year period is completed.

Follow-Up:

  • Patients will be monitored for long-term outcomes and survival after treatment ends.
  • If patients stop one drug due to side effects or near complete response, they may continue with the other drug.
  • Adjustments to enfortumab vedotin doses are allowed, but pembrolizumab doses will remain the same.

The study aims to find out if this treatment plan can effectively manage metastatic urothelial carcinoma and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed advanced urothelial carcinoma that cannot be removed by surgery.
  • Should not have received previous treatment for metastatic disease.
  • Must have at least one tumor that can be measured.
  • May have had previous immune therapy for localized cancer if it was completed at least 12 months ago.
  • Must be in good general health with an ECOG performance status of 0 to 2.
  • Must be able to understand and sign a consent form.
  • Must provide a tumor sample if available.
  • Must have normal organ and bone marrow function, including:
    • Neutrophil count over 1,000/mm³
    • Platelet count over 100,000/µl
    • Hemoglobin over 8.0 g/dL
    • Liver enzymes within specified limits
    • Creatinine clearance over 20 ml/min

Exclusion Criteria

  • Cannot have received certain previous treatments for urothelial cancer.
  • Cannot have significant nerve damage or uncontrolled diabetes.
  • Cannot have untreated or unstable brain metastases.
  • Cannot have serious uncontrolled illnesses or infections.
  • Cannot have had another invasive cancer within the last 3 years, except for certain cases.
  • Cannot be on certain medications or have certain infections like HIV.
  • Cannot have a history of certain lung diseases or organ transplants.
  • Cannot have active tuberculosis or be pregnant or breastfeeding.
  • Cannot have active autoimmune diseases requiring treatment in the past 2 years, except for certain conditions like stable thyroid disease or diabetes.
  • Cannot be on high doses of steroids or have had previous immunotherapy for metastatic urothelial cancer that caused severe side effects.

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