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 or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
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Health Professionals
What is the purpose of this trial?
A global phase 3, multicenter, randomized, trial, 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 or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.
The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC).
Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system.
In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Alison Johnson
- Anca Bulgaru, MD
- Armand Russo, MD
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Clarice Grens
- D. Barry Boyd, MD, MS
- Emily Kopas, APRN, OCN
- Jade Vanacore
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jeremy Kortmansky, MD
- Jose Morales-Marin
- Joseph Kim, MD
- Karishma Mehra, MBBS
- Kayla Martello
- Kristen Hoxie
- Larisa Fleysher
- Laura Sabourin
- Lynn Mastrianni
- M. Sung Lee, MD
- Madeline Santiago
- Matthew Austin, MD
- Michael Burke
- Michael Hurwitz, MD, PhD
- Michelle Laspino
- Osarugue Otasowie
- Pawan Karanam, MD
- Rebecca Vanasse-Passas, MD
- Robert Legare, MD
- Sara Anastasio, RN
- Stephen Lattanzi, MD
- Vidya Kesavan
- Virginia Syombathy
- Zia Rahman, MD
- Last Updated08/28/2024
- Study HIC#2000033530