Continuation Study for Patients Who Completed a Previous Cancer Study with Durvalumab
Sponsor: AstraZeneca
ClinicalTrials ID:NCT05303532
This study allows patients who have finished a previous cancer study with the drug Durvalumab and are still benefiting from it to continue receiving the treatment. The decision to continue is based on the doctor's assessment.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to let patients who were part of a previous cancer study with Durvalumab continue their treatment if they are still benefiting from it. This decision is made by the doctor overseeing the treatment. Patients will continue to receive Durvalumab until they meet certain criteria to stop the treatment.
Description
This study, called ROSY-D, is open to patients who have completed a previous study with Durvalumab and are still seeing positive results from the treatment. It is an international study that allows these patients to continue receiving Durvalumab as long as they are benefiting from it, according to their doctor. Patients will be transferred from their original study to this one and will keep receiving the treatment until they meet specific conditions that require stopping.
Eligibility Criteria
Inclusion Criteria
- Must provide signed and dated written consent to participate.
- Must be currently benefiting from Durvalumab treatment in a previous study that has ended or reached its maximum duration.
- Must be able to receive a fixed dose of 1500 mg of Durvalumab every 4 weeks.
Exclusion Criteria
- Have ongoing severe side effects that require stopping treatment.
- Are taking any medications that are not allowed in this study.
- Are part of another medical study that conflicts with this one.
- Had to stop the previous study due to severe side effects or worsening of the disease.
- Have access to the drug for free through local regulations.
Additional exclusion criteria for the ROSY-D sub-study:
- Have an active infection like COVID-19, tuberculosis, hepatitis B or C, or HIV.
- Are of reproductive age and not using effective birth control during the study and for 90 days after the last dose.
- Have ongoing moderate side effects and cannot reduce steroid use to 10 mg of prednisone per day or less within 12 weeks after the last dose of the previous study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 92663 | Newport Beach | California |
| Research Site | 80218 | Denver | Colorado |
| Research Site | 38120 | Memphis | Tennessee |
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