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)
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 — From baseline up to follow up at 90 days after the last dose of study drug. 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).
Trial sites (123)
Facility
City
Region
Status
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.
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