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Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Sponsor: AstraZeneca
Summary
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 Cisplatin based chemotherapy 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 or the duplet combination of Durvalumab 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 677 patients, who will receive triplet combination, duplet combination or currently approved SOC in the main study. 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 + Enfortumab Vedotin and 2 cycles of Tremelimumab or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will receive either adjuvant Durvalumab or adjuvant Durvalumab and 1 cycle of Tremelimumab.
Official 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 or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
712
Start Date
2021-08-05
Completion Date
2028-09-08
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
Anti- PD-L1 Antibody
Tremelimumab
Human IgG2 mAb
Enfortumab Vedotin
Nectin-4-directed antibody and microtubule inhibitor conjugate
Radical Cystectomy
For cisplatin-ineligible or cisplatin-refusal patients
Locations (196)
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Orange, California, United States
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Santa Monica, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Coeur d'Alene, Idaho, United States
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Maywood, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Scarborough, Maine, United States
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Boston, Massachusetts, United States
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Brighton, Michigan, United States
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Jackson, Mississippi, United States
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Las Vegas, Nevada, United States
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Saddle Brook, New Jersey, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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Portland, Oregon, United States
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Hershey, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Norfolk, Virginia, United States
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Spokane, Washington, United States
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Buenos Aires, Argentina
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CABA, Argentina
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Ciudad de Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Pergamino, Argentina
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Graz, Austria
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Krems, Austria
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Linz, Austria
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Vienna, Austria
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Wiener Neustadt, Austria
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Barretos, Brazil
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Curitiba, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Santa Maria, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Săo Paulo, Brazil
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Uberlândia, Brazil
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Abbotsford British Columbia, British Columbia, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Santiago, Chile
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Santiago, Chile
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Amiens, France
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Bayonne, France
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Clermont-Ferrand, France
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Lille, France
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Lyon, France
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Marseille, France
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Marseille, France
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Montpellier, France
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Nice, France
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Pierre-Bénite, France
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Quint-Fonsegrives, France
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Saint-Priez En Jarez, France
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Strasbourg, France
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Suresnes, France
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Vandœuvre-lès-Nancy, France
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Bielefeld, Germany
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Bochum, Germany
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Cologne, Germany
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Düsseldorf, Germany
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Giessen, Germany
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Hanover, Germany
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Herne, Germany
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Magdeburg, Germany
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Mainz, Germany
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Mannheim, Germany
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München, Germany
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Münster, Germany
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Regensburg, Germany
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Reutlingen, Germany
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Ulm, Germany
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Athens, Greece
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Athens, Greece
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Maroussi, Athens, Greece
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Shatin, Hong Kong
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Hadera, Israel
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Tel Aviv, Israel
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Bari, Italy
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Florence, Italy
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Meldola, Italy