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Clinical Trials in India / NCT05303532
Enrolling by invitation Phase 3

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

NCT05303532 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-04-19
Last updated
2026-08-11

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Durvalumab

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

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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (123)

FacilityCityRegionStatus
Research Site Newport Beach California
Research Site Denver Colorado
Research Site Memphis Tennessee
Research Site Rosario Argentina
Research Site Box Hill Australia
Research Site Melbourne Australia
Research Site Charleroi Belgium
Research Site Barretos Brazil
Research Site São José do Rio Preto Brazil
Research Site Sofia Bulgaria
Research Site Sofia Bulgaria
Research Site Kingston Ontario
Research Site Newmarket Ontario
Research Site Toronto Ontario
Research Site Beijing China
Research Site Changsha China
Research Site Hangzhou China
Research Site Hangzhou China
Research Site Nanjing China
Research Site Shanghai China
Research Site Shenyang China
Research Site Wenzhou China
Research Site Xi'an China
Research Site Xiamen China
Research Site Olomouc Czechia
Research Site Besançon France
Research Site Bordeaux France
Research Site Brest France
Research Site Dijon France
Research Site Lyon France
Research Site Marseille France
Research Site Montpellier France
Research Site Rennes France
Research Site Rouen France
Research Site Saint-Herblain France
Research Site Strasbourg France
Research Site Toulouse France
Research Site Tours France
Research Site Villejuif France
Research Site Gütersloh Germany

+ 83 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05303532 on ClinicalTrials.gov ↗ ← All trials in India