IRB #

STUDY00023171

Title

A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)

Principal Investigator

Jacqueline Vuky

Study Purpose

We are doing this study to learn more about if the combination of medications called durvalumab, tremelimumab and enfortumab vedotin (EV) before and after surgery will work and be safe for the treatment of muscle invasive bladder cancer and also to better understand the studied disease and associated health problems.

Medical Condition(s)

Muscle Invasive Bladder Cancer (MIBC)

Eligibility Criteria

- Age 18 or older
- Documented Muscle-invasive transitional cell carcinoma (TCC) of the bladder with stage II or IIIA disease

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

You will be in the study for up to approximately 5 years (one year of dosing and up to 4 years of follow up). The follow up period of the study will continue even if you are on other treatments. Your participation in the study may need to be longer to get better answers to the study questions.

Minors Included

No

Contact

Knight Clinical Trials
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

AstraZeneca Pharmaceuticals LP

Recruitment End

07/31/2023

Compensation Provided

No


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