Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab
NCT ID: NCT05303532
Last Updated: 2025-11-26
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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ENROLLING_BY_INVITATION
PHASE3
61 participants
INTERVENTIONAL
2022-04-19
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Durvalumab
Participants will receive durvalumab.
Durvalumab
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.
Interventions
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Durvalumab
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.
Eligibility Criteria
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Inclusion Criteria
* Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AstraZeneca parent study using an AstraZeneca compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol.
* Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at study entry.
Exclusion Criteria
* Currently receiving treatment with any prohibited medication(s).
* Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological \[example: Response Evaluation Criteria in Solid Tumours\] progression or clinical progression).
* Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
* Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
* Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
* Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Newport Beach, California, United States
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Denver, Colorado, United States
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Memphis, Tennessee, United States
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Rosario, , Argentina
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Box Hill, , Australia
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Melbourne, , Australia
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Charleroi, , Belgium
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Barretos, , Brazil
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São José do Rio Preto, , Brazil
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Kingston, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Beijing, , China
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Beijing, , China
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Changsha, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Nanjing, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Wenzhou, , China
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Xi'an, , China
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Xiamen, , China
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Olomouc, , Czechia
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Besançon, , France
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Bordeaux, , France
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Brest, , France
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Dijon, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Rennes, , France
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Rouen, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Toulouse, , France
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Tours, , France
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Villejuif, , France
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Gütersloh, , Germany
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Münster, , Germany
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Oldenburg, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Győr, , Hungary
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Székesfehérvár, , Hungary
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Chennai, , India
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Arezzo, , Italy
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Bari, , Italy
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Catania, , Italy
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Meldola, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Padua, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Kanazawa, , Japan
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Kōtoku, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Saga, , Japan
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Sunto-gun, , Japan
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Kuching, , Malaysia
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Aguascalientes, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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Quezon City, , Philippines
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Elblag, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Suceava, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Busan, , South Korea
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Gwangju, , 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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Girona, , Spain
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Madrid, , Spain
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Marbella, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Lausanne, , Switzerland
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Hat Yai, , Thailand
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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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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Chernivtsi, , Ukraine
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Dnipro, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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London, , United Kingdom
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Sheffield, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hồ Chí Minh, , Vietnam
Countries
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Other Identifiers
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2021-003031-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4191C00137
Identifier Type: -
Identifier Source: org_study_id
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