Cancer
Conditions
Keywords
Cancer, Oncology, Clinically Benefit, Roll Over StudY, Durvalumab
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.
Detailed description
ROSY-D is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using durvalumab and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria.
Interventions
DRUGDurvalumab
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Mexico, Philippines, Poland, Romania, Russia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Outcome results
None listed