Durvalumab Long-Term Safety and Efficacy Study
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) information.
Checked against the public recordLast updated Dec 20, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- AstraZeneca
- Interventions being studied
- Drug: Durvalumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. 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. 2. 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. 3. 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). 4. Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures. Exclusion Criteria: The following exclusion criteria apply only to patients receiving treatment or retreatment: 1. 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 2. Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment 3. Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study 4. Diagnosis of a new primary malignancy since enrollment into the parent clinical study
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteFullerton, California
- Research SiteWashington D.C., District of Columbia
- Research SiteAugusta, Georgia
- Research SiteBaltimore, Maryland
- Research SiteMinneapolis, Minnesota
- Research SiteSt Louis, Missouri
- Research SiteMineola, New York
- Research SiteChapel Hill, North Carolina
- Research SiteHuntersville, North Carolina
- Research SiteGreenville, South Carolina
- Research SiteNashville, Tennessee
- Research SiteDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 20, 2024. Always confirm current availability with the study team.