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Durvalumab Long-Term Safety and Efficacy Study

Trial Status: Active

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.

Inclusion Criteria

  • 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

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Joann Alimurong
Phone: 410-328-2703

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

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 with any other approved or investigational anticancer agents, in an eligible

AstraZeneca/MedImmune-sponsored clinical study.

Trial Phase Phase IV

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D910FC00001
  • Secondary IDs NCI-2020-01298
  • Clinicaltrials.gov ID NCT04078152