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EV-103: A Clinical Trial for the Treatment of Urothelial Cancer

Cohort K: Enfortumab vedotin (EV) alone or in combination with pembrolizumab in first line cisplatin-ineligible subjects with locally advanced or metastatic urothelial cancer

Trial ID: NCT03288545

Trial Details

In this part of the study (Cohort K), we want to find out if giving enfortumab vedotin alone is better or worse than giving enfortumab vedotin with pembrolizumab for urothelial cancer. We also want to find out about the side effects of giving enfortumab vedotin alone or enfortumab vedotin with pembrolizumab for urothelial cancer.

Half of the participants will get enfortumab vedotin alone. The other half will get enfortumab vedotin and pembrolizumab. If you take part in this study, whether you get enfortumab vedotin alone or enfortumab vedotin with pembrolizumab will be chosen randomly, like tossing a coin. This is an open-label study, which means both the study doctor and you will know the treatment you are receiving. USM/EVM/2021/0009

Estimated Enrollment

In Cohort K, the clinical trial is planning to enroll about 150 participants

Phase

2

Eligibility Criteria

Participants must:
  • Be 18 years or older
  • Have been diagnosed with urothelial cancer, cancer of the urinary tract including the bladder, renal pelvis, ureter, or urethra
  • Have locally advanced or metastatic urothelial cancer, meaning that it has recently grown or spread
  • Have urothelial cancer that cannot be removed by surgery
Participants must not:
  • Received any prior treatment for their locally advanced or metastatic urothelial cancer
  • Cancer that has spread to your nerves or spine (central nervous system)
  • Conditions requiring high doses of steroids or other immunosuppressive medications
  • Have an allogenic stem cell or solid organ transplant
  • Had a heart attack or stroke within the last 6 months
  • Uncontrolled diabetes mellitus

Check Eligibility

We’ll check to see if you are eligible by asking you some questions.

Get Started

What Will Happen in the Study?

  1. You decide if you want to participate in the study. You will schedule a visit with the study site to meet with the study doctor and team, review the informed consent form, and learn more about the study.
  2. After you chose to participate, we will ask you questions about your medical history, and tests will be done to make sure you are a good candidate for the study and qualify to join. A small part of your tumor tissue will be sent for research testing. This could be from an earlier biopsy or we may perform a new biopsy. We will also do an eye exam and some scans.
  3. If you are qualified for this study, you will start receiving the study medication in 3-week cycles.
  4. Tests will be done during the study to monitor your health and safety, and to check the status of your disease. Extra blood samples will be taken in addition to your normal medical care for this. We will also collect urine and tumor tissue samples.
  5. You will be asked to provide responses to some questions on paper or on an electronic device at home and during some of the clinic visits. The questionnaires will ask about things including how you are feeling, your daily activities, pain, medications, and any visits to the doctor or emergency room you have had.
  6. You will be monitored to see if the study drugs have an effect on your cancer. If your cancer stays the same or gets better, and as long as you don’t have any serious problems, you can continue to receive enfortumab vedotin until the study is closed. If you are in the group that gets pembrolizumab also, you can receive it up to 2 years (for a total of 35 cycles).
  7. We will collect your health information for up to 5 years. You don’t need insurance to join this clinical trial and compensation for travel may be available.

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Actively Recruiting

  • Chattanooga, Tennessee, United States
  • Kittanning, Pennsylvania, United States
  • Gilbert, Arizona, United States
  • Decatur, Illinois, United States
  • Atlanta, Georgia, United States
  • San Antonio, Texas, United States
  • Hackensack, New Jersey, United States
  • Myrtle Beach, South Carolina, United States
  • Geneva, Illinois, United States
  • Tyler, Texas, United States
  • Broomall, Pennsylvania, United States
  • Lincoln, Nebraska, United States
  • Rochester, New York, United States
  • Lansing, Michigan, United States
  • Washington, District of Columbia, United States
  • Canton, Ohio, United States
  • Spokane, Washington, United States
  • Detroit, Michigan, United States
  • Jackson, Mississippi, United States
  • Santa Rosa, California, United States
  • Norwich, Connecticut, United States
  • Greenville, North Carolina, United States
  • Greenville, South Carolina, United States
  • Boca Raton, Florida, United States
  • St. Louis, Missouri, United States
  • Fairhaven, Massachusetts, United States
  • Fayetteville, Arkansas, United States
  • Ft. Lauderdale, Florida, United States
  • New Orleans, Louisiana, United States

Currently Inactive

  • (Awaiting confirmation) Toledo, Ohio, United States
  • (Awaiting confirmation) Minneapolis, Minnesota, United States
  • (Awaiting confirmation) Sacramento, California, United States
  • (Awaiting confirmation) Hershey, Pennsylvania, United States
  • (Awaiting confirmation) Tucson, Arizona, United States
  • (Awaiting confirmation) Las Vegas, Nevada, United States
  • (Awaiting confirmation) Rockville, Maryland, United States
  • (Awaiting confirmation) Orange, California, United States
  • (Awaiting confirmation) Albuquerque, New Mexico, United States
  • (Awaiting confirmation) Beverly Hills, California, United States

Frequently Asked Questions (FAQ)

Check Eligibility

We’ll check to see if you are eligible by asking you some questions.

Get Started