Policy Lab

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

EV-103: A Clinical Trial for Muscle Invasive Bladder Cancer (Cohort L)

A Phase 1b/2 study of enfortumab vedotin (EV) for the treatment of muscle invasive bladder cancer (MIBC) (ASG-22CE)

Trial ID: NCT03288545a

Seagen is dedicated to make sure that all patients are represented in our clinical trials. It is important to Seagen that the therapies that we make improve the lives of all people with cancer, including those who have been historically underrepresented due to their sex, race, ethnicity, or age. — - Seagen Commitment to Diversity & Inclusion

Trial Details

In this part of the study (Cohort L), we want to find out if giving enfortumab vedotin can treat muscle invasive bladder cancer before surgery and keep the cancer from returning after surgery. We will do this by looking at the tissue from the bladder cancer surgery; and by looking at how long it takes for bladder cancer to return after surgery.

All participants will get enfortumab vedotin before and after their surgery that will remove the bladder cancer. This is an open-label study, which means both the study doctor and you will know the treatment you are receiving.

Estimated Enrollment

In Cohort L, the clinical trial is planning to enroll about 50 Participants

Phase

2

Eligibility Criteria

Participants must:
  • Be 18 years or older
  • Have muscle invasive bladder cancer (MIBC)
  • Not be able to receive a type of chemotherapy called cisplatin
  • Be able to undergo surgery to remove the tumor in their bladder.
Participants must not:
  • Received any prior oral treatment; IV treatment; or radiation for their muscle invasive bladder cancer.
  • Received any prior treatment with an immunotherapy/checkpoint inhibitor drug like KEYTRUDA® (pembrolizumab), OPDIVO® (nivolumab), TECENTRIQ® (atezolizumab), Bavencio® (avelumab) or IMFINZI® (durvalumab)
  • Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
  • Cancer that has spread to your nerves, spine (central nervous system) or other organs.
  • Conditions requiring high doses of steroids or other immunosuppressive medications
  • Had an allogenic stem cell or solid organ transplant
  • Had a heart attack or stroke within the last 6 months
  • History of autoimmune disease
  • Uncontrolled diabetes mellitus

What Will Happen in the Study?

  1. You decide if you want to participate in 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 perform 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 have surgery to remove the bladder cancer. Tissue from this surgery will be sent for research testing.
  7. You will be monitored to see if the study drug has an effect on your cancer before surgery and if it prevents the cancer from returning after surgery.
  8. We will collect your health information for up to 5 years. You don’t need insurance to join this clinical trial and reimbursement 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 the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)