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

Last updated: April 22, 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:
January 07, 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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  • Research Site

    Box Hill, 3128
    Australia

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  • Research Site

    Melbourne, 3000
    Australia

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  • Research Site

    Charleroi, 6000
    Belgium

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  • Research Site

    Jette, 1090
    Belgium

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    Kortrijk, 8500
    Belgium

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  • Research Site

    Barretos, 14784-400
    Brazil

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  • Research Site

    Porto Alegre, 91350200
    Brazil

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    São José do Rio Preto, 15090-000
    Brazil

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    Sofia, 1618
    Bulgaria

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    Kingston, Ontario K7L 2V7
    Canada

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    Newmarket, Ontario L3Y 2P9
    Canada

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    Toronto, Ontario M5G 2M9
    Canada

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    Providencia, 7630372
    Chile

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    Beijing, 100142
    China

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    Changsha, 410013
    China

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    Hangzhou, 310009
    China

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    Jinan, 250031
    China

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    Nanjing, 210009
    China

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    Shanghai, 200030
    China

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    Shijiazhuang, 050011
    China

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    Wenzhou, 325000
    China

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    Xi'an, 710038
    China

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    Xiamen, 361003
    China

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    Olomouc, 779 00
    Czechia

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    Praha 2, 12808
    Czechia

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    Besançon Cedex, 25030
    France

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    Bordeaux Cedex, 33076
    France

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    Brest, 29200
    France

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    Dijon cedex, 21079
    France

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    Lille Cedex, 59037
    France

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    Lyon, 69373
    France

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    Marseille, 13005
    France

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    Montpellier, 34090
    France

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    Nimes, 30029
    France

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    Pierre Benite, 69495
    France

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    Rennes, 35042
    France

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    Rouen, 76031
    France

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    Saint Herblain, 44805
    France

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    Strasbourg, 67033
    France

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    Toulouse, 31059
    France

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    Toulouse Cedex 09, 31059
    France

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    Tours CEDEX, 37044
    France

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    Villejuif, 94805
    France

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    Dresden, 01307
    Germany

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    Erlangen, 91054
    Germany

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    Guetersloh, 33332
    Germany

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    Muenster, 48149
    Germany

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    Oldenburg, 26121
    Germany

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    Athens, 14564
    Greece

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    Budapest, 1083
    Hungary

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    Győr, 9024
    Hungary

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    Székesfehérvár, 8000
    Hungary

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    Chennai, 600035
    India

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    Arezzo, 52100
    Italy

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    Bari, 70124
    Italy

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    Catania, 95126
    Italy

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    Meldola, 47014
    Italy

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    Milan, 20141
    Italy

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    Milano, 20141
    Italy

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    Modena, 41125
    Italy

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    Padova, 35128
    Italy

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    Palermo, 90146
    Italy

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    Pisa, 56126
    Italy

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    Roma, 00152
    Italy

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    Rozzano, 20089
    Italy

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    Terni, 05100
    Italy

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    Bunkyo-ku, 113-8677
    Japan

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    Fukuoka-shi, 812-8582
    Japan

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    Kanazawa-shi, 920-8641
    Japan

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    Koto-ku, 135-8550
    Japan

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  • Research Site

    Nagasaki-shi, 852-8501
    Japan

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    Nagoya-shi, 466-8560
    Japan

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    Okayama-shi, 700-8607
    Japan

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    Saga-shi, 840-8571
    Japan

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    Sunto-gun, 411-8777
    Japan

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    Busan, 49241
    Korea, Republic of

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    Gwangju, 61469
    Korea, Republic of

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    Seoul, 06351
    Korea, Republic of

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    Kuching, 93200
    Malaysia

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    Aguascalientes, 20230
    Mexico

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    Mexico City, 0 3100
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    Mérida, 97134
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    Quezon City, 1101
    Philippines

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    Białystok, 15-027
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    Bydgoszcz, 85-796
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    Elbląg, 02-300
    Poland

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    Olsztyn, 10-357
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    Szczecin, 71-730
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    Warszawa, 02-781
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    Łódź, 90-302
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    Suceava, 720214
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    Moscow, 115516
    Russian Federation

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    Nizhniy Novgorod, 603001
    Russian Federation

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    Novosibirsk, 630108
    Russian Federation

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    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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    Barcelona, 08025
    Spain

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    Girona, 17007
    Spain

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    Madrid, 28046
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    Marbella, 29603
    Spain

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    Santiago De Compostela (A Coruña), 15706
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    Santiago de Compostela, 15706
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    Valencia, 46009
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    Lausanne, CH-1011
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    Taichung,
    Taiwan

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    Tainan, 704
    Taiwan

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    Taipei City, 112
    Taiwan

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    Taoyuan, 333
    Taiwan

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    Bangkok, 10330
    Thailand

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    Chiang Mai, 50200
    Thailand

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    Hat Yai, 90110
    Thailand

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    Ankara, 06590
    Turkey

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  • Research Site

    Bursa, 16059
    Turkey

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    Istanbul, 34098
    Turkey

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    Izmir, 35100
    Turkey

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  • Research Site

    Yüreğir, 01240
    Turkey

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  • Research Site

    Çankaya, 06680
    Turkey

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    Chernivtsi, 58013
    Ukraine

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    Dnipro, 49102
    Ukraine

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    Ivano-Frankivsk, 76018
    Ukraine

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  • Research Site

    Kryvyi Rih, 50000
    Ukraine

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    Kyiv, 88014
    Ukraine

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    Uzhhorod, 88014
    Ukraine

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  • Research Site

    Vinnytsia, 21029
    Ukraine

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    London, EC1A 7BE
    United Kingdom

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    Sheffield, S10 2SJ
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    Los Angeles, California 90095-1740
    United States

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    Newport Beach, California 92663
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    Washington, District of Columbia 20007
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    Fort Myers, Florida 33908
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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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    Houston, Texas 77090
    United States

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    Hanoi, 100000
    Vietnam

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  • Research Site

    Ho Chi Minh, 70000
    Vietnam

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  • Research Site

    Ho Chi Minh city, 700000
    Vietnam

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