Status:
COMPLETED
Durvalumab Long-Term Safety and Efficacy Study
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Iqvia Pty Ltd
Parexel
Conditions:
Solid Tumor
Eligibility:
All Genders
18-130 years
Phase:
PHASE4
Brief Summary
The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) inform...
Detailed Description
This is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination wi...
Eligibility Criteria
Inclusion
- Patient must be 18 years or older, at the time of signing the ICF. For subjects aged \< 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
- Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.
- Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen).
- Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.
Exclusion
- The following exclusion criteria apply only to patients receiving treatment or retreatment:
- Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab
- Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
- Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study
- Diagnosis of a new primary malignancy since enrollment into the parent clinical study
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT04078152
Start Date
September 5 2019
End Date
October 31 2024
Last Update
December 20 2024
Active Locations (116)
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1
Research Site
Fullerton, California, United States, 92835
2
Research Site
Washington D.C., District of Columbia, United States, 20007
3
Research Site
Augusta, Georgia, United States, 30912
4
Research Site
Baltimore, Maryland, United States, 21201