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
NCT ID: NCT04960709
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
712 participants
INTERVENTIONAL
2021-08-05
2028-09-08
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Durvalumab + Tremelimumab + Enfortumab Vedotin
Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin and 2 cycles of Tremelimumab, followed by radical cystectomy, followed by 1 cycle of postoperative Tremelimumab and 9 cycles of Durvalumab. Each postoperative cycle is 28 days.
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
Durvalumab + Enfortumab vedotin
Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 9 cycles of Durvalumab. Each postoperative cycle is 28 days.
Durvalumab
Anti- PD-L1 Antibody
Enfortumab Vedotin
Nectin-4-directed antibody and microtubule inhibitor conjugate
Radical Cystectomy
For cisplatin-ineligible or cisplatin-refusal patients
Cystectomy with or without approved Adjuvant Therapy.
Participants may receive SoC (nivolumab approved as adjuvant treatment for MIBC based on high risk criteria) per approved label in the country OR Participants receive standard of care surgery (radical cystectomy) alone.
Radical Cystectomy
For cisplatin-ineligible or cisplatin-refusal patients
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with transitional cell and mixed transitional/non-transitional cell histologies;
* Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0 (participants with T1 stage are allowed only with N1 disease)
* Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.
* Medically fit for cystectomy and able to receive neoadjuvant therapy;
* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
* ECOG performance status of 0,1,2 at enrollment.
* Availability of tumor sample prior to study entry;
* Must have a life expectancy of at least 12 weeks at randomization.
* Cisplatin-ineligible, following criteria based on Galsky et al 2011 OR Refuse cisplatin based chemotherapy (must be documented in the medical records)
Exclusion Criteria
* Active infection
* Uncontrolled intercurrent illness
* Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin \[BCG\]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
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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Pilar, , Argentina
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Graz, , Austria
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Krems, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , 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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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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Santo André, , 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, 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
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Milan, , Italy
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Milan, , Italy
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Padua, , Italy
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Pozzuoli, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Terni, , Italy
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Tricase, , Italy
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Verona, , Italy
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Hamamatsu, , Japan
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Ichikawa-shi, , Japan
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Kanazawa, , Japan
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Kashihara-shi, , Japan
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Kawasaki-shi, , Japan
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Kita-gun, , Japan
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Kobe, , Japan
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Kumamoto, , Japan
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Matsuyama, , Japan
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Miyazaki, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Toyama, , Japan
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Tsukuba, , Japan
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Yokohama, , Japan
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Colima, , Mexico
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Monterrey, , Mexico
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Arnhem, , Netherlands
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Breda, , Netherlands
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Groningen, , Netherlands
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Hoofddorp, , Netherlands
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Leiden, , Netherlands
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Utrecht, , Netherlands
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Gdansk, , Poland
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Nowa Sól, , Poland
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Skórzewo, , Poland
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Warsaw, , Poland
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Braga, , Portugal
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Coimbra, , Portugal
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Faro, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Busan, , South Korea
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Goyang-si, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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L'Hospitalet de Llobregat, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Tainan, , Taiwan
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Bangkok, , Thailand
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Dusit, , Thailand
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Songkhla, , Thailand
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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London, , United Kingdom
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London, , United Kingdom
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Huế, , Vietnam
Countries
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Other Identifiers
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2020-005452-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D910PC00001
Identifier Type: -
Identifier Source: org_study_id