Cancer patients who respond to drug get continued access in new study

NCT ID NCT05303532

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This study offers ongoing treatment with the cancer drug durvalumab to people who have already completed a previous study and are still benefiting from the drug, as decided by their doctor. The main goal is to monitor safety and side effects. About 214 participants will be enrolled.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, 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. There are no additional inclusion criteria for the ROSY-D sub-study. Exclusion Criteria: The Core Protocol exclusion criteria are. * Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at 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 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. The additional exclusion criteria for the ROSY-D sub-study are: * 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.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

123 sites in 31 countries. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Research Site

Newport Beach, California, 92663, United States
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Denver, Colorado, 80218, United States
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Memphis, Tennessee, 38120, United States
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Rosario, S2000KZE, Argentina
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Box Hill, 3128, Australia
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Melbourne, 3000, Australia
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Charleroi, 6000, Belgium
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Barretos, 14784-400, Brazil
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São José do Rio Preto, 15090-000, Brazil
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Sofia, 1612, Bulgaria
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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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Beijing, 100142, China
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Changsha, 410013, China
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Hangzhou, 310003, China
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Hangzhou, 310009, China
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Nanjing, 210009, China
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Shanghai, 200030, China
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Shenyang, 110042, China
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Wenzhou, 325000, China
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Xi'an, 710061, China
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Xiamen, 361003, China
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Olomouc, 779 00, Czechia
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Besançon, 25030, France
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Bordeaux, 33076, France
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Brest, 29200, France
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Dijon, 21079, 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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Rennes, 35042, France
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Rouen, 76031, France
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Saint-Herblain, 44805, France
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Strasbourg, 67200, France
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Toulouse, 31059, France
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Tours, 37044, France
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Villejuif, 94805, France
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Gütersloh, 33332, Germany
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Münster, 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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Modena, 41125, Italy
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Padova, 35128, Italy
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Pisa, 56126, Italy
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Roma, 00128, Italy
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Roma, 00152, Italy
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Bunkyō City, 113-8677, Japan
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Fukuoka, 812-8582, Japan
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Kanazawa, 920-8641, Japan
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Kōtoku, 135-8550, Japan
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Nagoya, 466-8560, Japan
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Okayama, 700-8607, Japan
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Saga, 840-8571, Japan
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Sunto-gun, 411-8777, Japan
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Kuching, 93200, Malaysia
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Mexico City, 0 3100, Mexico
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Mérida, 97134, Mexico
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Quezon City, 1101, Philippines
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Bialystok, 15-027, Poland
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Bydgoszcz, 85-796, Poland
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Elblag, 02-300, Poland
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Lodz, 90-302, Poland
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Lodz, 93-513, Poland
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Olsztyn, 10-357, Poland
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Szczecin, 71-730, Poland
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Warsaw, 02-781, Poland
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Suceava, 720214, Romania
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Moscow, 105229, Russia
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Moscow, 115478, Russia
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Nizhny Novgorod, 603001, Russia
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Novosibirsk, 630108, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 196603, Russia
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Saint Petersburg, 197758, Russia
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Busan, 49241, South Korea
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Gwangju, 61469, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Barcelona, 08025, Spain
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Barcelona, 08035, Spain
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Girona, 17007, Spain
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Madrid, 28046, Spain
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Marbella, 29603, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46009, Spain
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Lausanne, CH-1011, Switzerland
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Taichung, 404, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 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, 06010, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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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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Kyiv, 88014, Ukraine
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Uzhhorod, 88014, Ukraine
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Vinnytsia, 21029, Ukraine
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London, EC1A 7BE, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hồ Chí Minh, 700000, Vietnam

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