Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab
Part of paid clinical trials in Newport Beach, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT05303532
- Phase
- PHASE3
- Status
- Enrolling By Invitation
Conditions
- Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Durvalumab — DRUGFixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.
Study Details
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.
Key Dates
- Start date
- Apr 19, 2022
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 214 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: DurvalumabParticipants will receive durvalumab.
Primary Outcome Measure
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: From baseline up to follow up at 90 days after the last dose of study drug. ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Newport Beach | California | 92663 | - |
| Research Site | Denver | Colorado | 80218 | - |
| Research Site | Memphis | Tennessee | 38120 | - |
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