Durvalumab Long-Term Safety and Efficacy Study

Completed · Phase 4

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT04078152

Run by

AstraZeneca

People needed

163

Starts

2019-09-05

Expected to finish

2024-10-31

Last updated by the study team

2024-12-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Mineola, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Huntersville, North Carolina, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Rosario, Argentina
• Research Site — Box Hill, Australia
• Research Site — Melbourne, Australia
• Research Site — Brussels, Belgium
• Research Site — Kortrijk, Belgium
• Research Site — Leuven, Belgium
• Research Site — Florianópolis, Brazil
• Research Site — Ijuí, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — São José do Rio Preto, Brazil
• Research Site — Sofia, Bulgaria
• Research Site — Calgary, Alberta, Canada
• Research Site — Toronto, CA, Canada
• Research Site — Fullerton, California, United States

Full record on ClinicalTrials.gov

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