Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab

Last updated: November 25, 2025
Sponsor: AstraZeneca
Overall Status: Active - Enrolling

Phase

3

Condition

Neoplasms

Cancer

Treatment

Durvalumab

Clinical Study ID

NCT05303532
D4191C00137
2021-003031-29
  • Ages 18-99
  • All Genders

Study Summary

The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The Core Protocol inclusion criteria are:

  • Provision of signed and dated, written Informed Consent Form (ICF).

  • Patient is currently deriving clinical benefit, as judged by the investigator, fromcontinued treatment in an AstraZeneca parent study using an AstraZeneca compoundthat has met its endpoints, or has otherwise stopped, or the patient has reachedmaximum treatment duration allowed in the parent study's protocol.

  • Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at studyentry.

There are no additional inclusion criteria for the ROSY-D sub-study.

Exclusion

Exclusion Criteria:

The Core Protocol exclusion criteria are.

  • Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatmentat the time of the termination of the parent study.

  • Currently receiving treatment with any prohibited medication(s).

  • Concurrently enrolled in any other type of medical research judged not to bescientifically or medically compatible with this study.

  • Permanent discontinuation from the parent study due to toxicity or diseaseprogression (increase in the severity of the disease under study and/or increases inthe symptoms of a patient's condition attributable to the disease, as assessed anddocumented by the Investigator. Physician-defined progression can be radiological [example: Response Evaluation Criteria in Solid Tumours] progression or clinicalprogression).

  • Local access to commercially-available drug at no cost to the patient as permittedby local/country regulation.

The additional exclusion criteria for the ROSY-D sub-study are:

  • Active infection including Coronavirus disease 2019 (Polymerase chain reactionconfirmed and/or clinically suspected), tuberculosis, hepatitis B (known positiveHepatitis B virus (HBV) surface antigen result), hepatitis C, or Humanimmunodeficiency virus (HIV) (positive HIV 1/2 antibodies).

  • Male or female patients of reproductive potential who are not willing to employeffective birth control from study inclusion up to 90 days after the last dose ofdurvalumab monotherapy.

  • Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid toa dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after lastdose of study treatment/study regimen, per Toxicity Dose Modification and TMGs forImmune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines ofthe parent study.

Study Design

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: Durvalumab
Phase: 3
Study Start date:
April 19, 2022
Estimated Completion Date:
December 31, 2026

Study Description

ROSY-D is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using durvalumab and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria.

Connect with a study center

  • Research Site

    Rosario, S2000KZE
    Argentina

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    Rosario 3838583, S2000KZE
    Argentina

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    Box Hill, 3128
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    Box Hill 2174360, 3128
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    Melbourne, 3000
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    Melbourne 2158177, 3000
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    Charleroi, 6000
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    Charleroi 2800481, 6000
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    Jette, 1090
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    Kortrijk, 8500
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    Barretos, 14784-400
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    Barretos 3470451, 14784-400
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    Porto Alegre, 91350200
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    São José do Rio Preto, 15090-000
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    São José do Rio Preto 3448639, 15090-000
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    Sofia, 1612
    Bulgaria

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    Sofia 727011, 1612
    Bulgaria

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    Kingston, Ontario K7L 2V7
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    Newmarket, Ontario L3Y 2P9
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    Toronto, Ontario M5G 2M9
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    Kingston 5992500, Ontario 6093943 K7L 2V7
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    Newmarket 6087701, Ontario 6093943 L3Y 2P9
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    Toronto 6167865, Ontario 6093943 M5G 2M9
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    Providencia, 7630372
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    Beijing, 100853
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    Beijing 1816670, 100853
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    Changsha, 410013
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    Changsha 1815577, 410013
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    Hangzhou, 310009
    China

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    Hangzhou 1808926, 310003
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    Jinan, 250031
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    Nanjing, 210009
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    Nanjing 1799962, 210009
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    Shanghai, 200030
    China

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    Shanghai 1796236, 200433
    China

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    Shenyang 2034937, 110042
    China

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    Shijiazhuang, 050011
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    Wenzhou, 325000
    China

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    Wenzhou 1791388, 325000
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    Xi'an, 710038
    China

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    Xi'an 1790630, 710061
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    Xiamen, 361003
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    Xiamen 1790645, 361003
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    Olomouc, 779 00
    Czechia

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    Olomouc 3069011, 779 00
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    Praha 2, 12808
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    Besançon 3033123, 25030
    France

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    Besançon Cedex, 25030
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    Bordeaux 3031582, 33076
    France

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    Bordeaux Cedex, 33076
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    Brest, 29200
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    Brest 3030300, 29200
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    Dijon 3021372, 21079
    France

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    Dijon cedex, 21079
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    Lille Cedex, 59037
    France

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    Lyon, 69373
    France

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    Lyon 2996944, 69373
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    Marseille, 13005
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    Marseille 2995469, 13005
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    Montpellier, 34090
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    Montpellier 2992166, 34090
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    Nimes, 30029
    France

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    Pierre Benite, 69495
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    Rennes, 35042
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    Rennes 2983990, 35042
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    Rouen, 76031
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    Rouen 2982652, 76031
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    Saint Herblain, 44805
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    Saint-Herblain 2979590, 44805
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    Strasbourg, 67200
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    Strasbourg 2973783, 67200
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    Toulouse, 31059
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    Toulouse 2972315, 31059
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    Toulouse Cedex 09, 31059
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    Tours 2972191, 37044
    France

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    Tours CEDEX, 37044
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    Villejuif, 94805
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    Villejuif 2968705, 94805
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    Dresden, 01307
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    Erlangen, 91054
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    Guetersloh, 33332
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    Gütersloh 2913366, 33332
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    Muenster, 48149
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    Münster 2867543, 48149
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    Oldenburg, 26121
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    Oldenburg 2857458, 26121
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    Athens, 14564
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    Athens 264371, 14564
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    Budapest, 1121
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    Budapest 3054643, 1083
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    Győr, 9024
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    Győr 3052009, 9024
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    Székesfehérvár, 8000
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    Székesfehérvár 3044774, 8000
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    Chennai, 600035
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    Chennai 1264527, 600035
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    Arezzo, 52100
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    Arezzo 3182884, 52100
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    Bari, 70124
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    Bari 3182351, 70124
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    Catania, 95126
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    Catania 2525068, 95126
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    Meldola, 47014
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    Meldola 3173635, 47014
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    Milan, 20141
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    Milan 3173435, 20141
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    Milan 6951411, 20133
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    Milano, 20133
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    Modena, 41125
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    Modena 3173331, 41125
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    Padova, 35128
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    Padua 3171728, 35128
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    Palermo, 90146
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    Pisa, 56126
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    Pisa 3170647, 56126
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    Roma, 00152
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    Roma 8957247, 00128
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    Rozzano, 20089
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    Terni, 05100
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    Bunkyo-ku, 113-8677
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    Bunkyō City 11790632, 113-8677
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    Fukuoka 1863967, 812-8582
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    Fukuoka-shi, 812-8582
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    Kanazawa 1860243, 920-8641
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    Kanazawa-shi, 920-8641
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    Koto-ku, 135-8550
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    Kōtoku 2128852, 135-8550
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    Nagasaki-shi, 852-8501
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    Nagoya 1856057, 466-8560
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    Nagoya-shi, 466-8560
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    Okayama 1854383, 700-8607
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    Okayama-shi, 700-8607
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    Saga 1853303, 840-8571
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    Saga-shi, 840-8571
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    Sunto-gun, 411-8777
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    Busan, 49241
    Korea, Republic of

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    Gwangju, 61469
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    Seoul, 03080
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    Kuching, 93200
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    Kuching 1735634, 93200
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    Aguascalientes, 20230
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    Aguascalientes 4019233, 20230
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    Mexico City, 0 3100
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    Mexico City 3530597, 0 3100
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    Mérida, 97134
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    Mérida 3523349, 97134
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    Quezon City, 1101
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    Quezon City 1692192, 1101
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    Bialystok 776069, 15-027
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    Białystok, 15-027
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    Bydgoszcz, 85-796
    Poland

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    Bydgoszcz 3102014, 85-796
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  • Research Site

    Elblag 3099759, 02-300
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    Elbląg, 02-300
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    Lodz 3093133, 93-513
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    Olsztyn, 10-357
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    Olsztyn 763166, 10-357
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    Szczecin, 71-730
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  • Research Site

    Szczecin 3083829, 71-730
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    Warsaw 756135, 02-781
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    Warszawa, 02-781
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    Łódź, 93-513
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    Suceava, 720214
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    Suceava 665850, 720214
    Romania

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    Moscow 524901, 115478
    Russia

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  • Research Site

    Nizhny Novgorod 520555, 603001
    Russia

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  • Research Site

    Novosibirsk 1496747, 630108
    Russia

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    Omsk 1496153, 644013
    Russia

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  • Research Site

    Saint Petersburg 498817, 196603
    Russia

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  • Research Site

    Moscow, 115478
    Russian Federation

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  • Research Site

    Nizhniy Novgorod, 603001
    Russian Federation

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    Novosibirsk, 630108
    Russian Federation

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  • Research Site

    Obninsk, 249036
    Russian Federation

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    Omsk, 644013
    Russian Federation

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    Saint Petersburg, 197758
    Russian Federation

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    Saint-Petersburg, 196603
    Russian Federation

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    Singapore, 119074
    Singapore

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    Singapore 1880252, 168583
    Singapore

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    Busan 1838524, 49241
    South Korea

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  • Research Site

    Gwangju 1841811, 61469
    South Korea

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    Seoul 1835848, 03080
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    Barcelona, 08025
    Spain

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    Barcelona 3128760, 08035
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    Girona, 17007
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    Girona 3121456, 17007
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    Madrid, 28046
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    Madrid 3117735, 28046
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    Marbella, 29603
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    Marbella 2514169, 29603
    Spain

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    Santiago De Compostela (A Coruña), 15706
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    Santiago de Compostela, 15706
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    Santiago de Compostela 3109642, 15706
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    Valencia, 46009
    Spain

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  • Research Site

    Valencia 2509954, 46009
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    Lausanne, CH-1011
    Switzerland

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    Lausanne 2659994, CH-1011
    Switzerland

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    Taichung, 404
    Taiwan

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  • Research Site

    Taichung 1668399, 404
    Taiwan

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    Tainan, 704
    Taiwan

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  • Research Site

    Tainan 1668355, 704
    Taiwan

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    Tainan City 1668355, 704
    Taiwan

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    Taipei, 112
    Taiwan

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    Taipei 1668341, 112
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    Taipei City, 112
    Taiwan

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    Taoyuan, 333
    Taiwan

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    Taoyuan District 1667905, 333
    Taiwan

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    Bangkok, 10330
    Thailand

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    Bangkok 1609350, 10330
    Thailand

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    Chiang Mai, 50200
    Thailand

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    Chiang Mai 1153671, 50200
    Thailand

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    Hat Yai, 90110
    Thailand

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    Hat Yai 1610780, 90110
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    Ankara, 06230
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    Bursa, 16059
    Turkey

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    Istanbul, 34098
    Turkey

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    Izmir, 35100
    Turkey

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    Yüreğir, 01240
    Turkey

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    Çankaya, 06680
    Turkey

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    Ankara 323786, 06010
    Turkey (Türkiye)

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  • Research Site

    Bursa 750269, 16059
    Turkey (Türkiye)

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    Istanbul 745044, 34098
    Turkey (Türkiye)

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    Izmir 311046, 35100
    Turkey (Türkiye)

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    Chernivtsi, 58013
    Ukraine

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    Chernivtsi 710719, 58013
    Ukraine

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    Dnipro, 49102
    Ukraine

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    Dnipro 709930, 49102
    Ukraine

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    Ivano-Frankivsk, 76018
    Ukraine

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  • Research Site

    Ivano-Frankivsk 707471, 76018
    Ukraine

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    Kryvyi Rih, 50000
    Ukraine

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    Kyiv, 88014
    Ukraine

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  • Research Site

    Kyiv 703448, 88014
    Ukraine

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    Uzhhorod, 88014
    Ukraine

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    Uzhhorod 690548, 88014
    Ukraine

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    Vinnytsia, 21029
    Ukraine

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  • Research Site

    Vinnytsia 689558, 21029
    Ukraine

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    London, EC1A 7BE
    United Kingdom

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  • Research Site

    London 2643743, EC1A 7BE
    United Kingdom

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    Sheffield, S10 2SJ
    United Kingdom

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    Sheffield 2638077, S10 2SJ
    United Kingdom

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    Los Angeles, California 90095-1740
    United States

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    Newport Beach, California 92663
    United States

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    Newport Beach 5376890, California 5332921 92663
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    Denver, Colorado 80218
    United States

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  • Research Site

    Denver 5419384, Colorado 5417618 80218
    United States

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    Washington, District of Columbia 20007
    United States

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    Fort Myers, Florida 33908
    United States

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    Baltimore, Maryland 21201
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    Mineola, New York 11501
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    New York, New York 10065
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    Memphis, Tennessee 38120
    United States

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    Nashville, Tennessee 37203
    United States

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    Memphis 4641239, Tennessee 4662168 38120
    United States

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    Houston, Texas 77090
    United States

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    Hanoi, 100000
    Vietnam

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  • Research Site

    Hanoi 1581130, 100000
    Vietnam

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    Ho Chi Minh, 70000
    Vietnam

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    Ho Chi Minh City 1566083, 70000
    Vietnam

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    Ho Chi Minh city, 700000
    Vietnam

    Site Not Available

  • Research Site

    Hồ Chí Minh, 700000
    Vietnam

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