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

NCT05303532 | Enrolling By Invitation Phase 3 FDA Drug

• 2 other identifiers: D4191C001372021-003031-29
• Study Type: interventional
• Target: 214
• Locations: 31 countries
• Sites: 123

Brief 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.

Conditions

Cancer

Keywords

Cancer; Oncology; Clinically Benefit; Roll Over StudY; Durvalumab

Outcome Measures

Primary Outcomes (1)

• Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  To monitor safety and tolerability of continuous study treatment to patients who continue to benefit at the end of the clinical trial by measuring the primary outcome of Serious Adverse Events (SAEs).

  From baseline up to follow up at 90 days after the last dose of study drug.

Study Arms (1)

Durvalumab

EXPERIMENTAL

Participants will receive durvalumab.

Drug: Durvalumab

Interventions

Durvalumab DRUG

Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.

Durvalumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (123)

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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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MeSH Terms

Conditions

Neoplasms

Interventions

durvalumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 31, 2022
• Study Start: April 19, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

HU (3); CA (3); IN (1); PL (8); AU (2); CZ (1); JP (8); DE (3); RO (1); TH (3); CN (10); FR (14); KR (5); BR (2); BE (1); RU (7); AR (1); TW (5); MY (1); GR (1); IT (10); US (3); UA (6); PH (1); ME (2); CH (1); BU (2); TU (6); VN (3); ES (7); GB (2)