Study on Enfortumab Vedotin Alone or Combined with Other Treatments for Urothelial Cancer

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03288545

Provider View

This clinical trial is exploring the use of enfortumab vedotin, an experimental drug, alone and in combination with other cancer treatments for patients with urothelial cancer, which affects the urinary system. The study aims to understand the side effects and effectiveness of these treatments in shrinking tumors.

Patient Parameters

Program Overview

The study is testing enfortumab vedotin, an experimental drug, both by itself and with other cancer treatments, to see if it can help treat urothelial cancer. This type of cancer affects areas like the bladder, ureter, and urethra. The study will look at two main types of cancer: locally advanced or metastatic urothelial cancer, where the cancer has spread, and muscle-invasive bladder cancer, where the cancer has grown into the bladder muscle. Researchers want to find out if these treatments can shrink the cancer and what side effects they might cause.

Description

This study is investigating the safety and effectiveness of enfortumab vedotin (EV) when given alone or with other cancer treatments for patients with urothelial cancer. The study is divided into different parts:

For locally advanced or metastatic urothelial cancer:

  • Dose escalation and expansion phases to find the best dose and see how well the treatment works.
  • Different groups (Cohorts A, B, D, E, F, G, and K) will receive various combinations of treatments to see which works best.

For muscle-invasive bladder cancer:

  • Different groups (Cohorts H, J, and L) will receive treatments to see how well they work before surgery.

The main goal is to determine how safe and effective enfortumab vedotin is, both alone and with other treatments like pembrolizumab and chemotherapy. The study will also look at how well the cancer responds to these treatments and what side effects occur.

Eligibility Criteria

Inclusion Criteria

  • Have locally advanced or metastatic urothelial cancer or muscle-invasive bladder cancer.
  • For locally advanced or metastatic cancer, must meet specific health criteria and be eligible for certain treatments like pembrolizumab.
  • For muscle-invasive bladder cancer, must have a specific type of cancer and be unable to receive cisplatin-based chemotherapy.
  • Must have a good performance status and a life expectancy of at least 3 months.
  • Must provide a tumor sample for analysis before starting treatment.

Exclusion Criteria

  • Have received certain prior treatments, like PD-1 or PD-L1 inhibitors, except in specific cases.
  • Have ongoing nerve problems or active brain metastases.
  • Have significant side effects from previous treatments.
  • Require high doses of steroids or other immune-suppressing medications.
  • Have uncontrolled diabetes or other serious health conditions.
  • Have a history of another invasive cancer within the last 3 years.

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