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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.
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).
Time frame: From baseline up to follow up at 90 days after the last dose of study drug.
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Research Site
Newport Beach, California, United States
Research Site
Denver, Colorado, United States
Research Site
Memphis, Tennessee, United States
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
...and 113 more locations