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Durvalumab Long-Term Safety and Efficacy Study
Durvalumab Long-Term Safety and Efficacy Study

NCT04078152

CompletedPhase 4

Sponsor: AstraZeneca

Conditions: Solid Tumor

Interventions: Durvalumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (116)
  • Fullerton, California, United States
  • Washington D.C., District of Columbia, United States
  • Augusta, Georgia, United States
  • Baltimore, Maryland, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • Mineola, New York, United States
  • Chapel Hill, North Carolina, United States
  • Huntersville, North Carolina, United States
  • Greenville, South Carolina, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Rosario, Argentina
  • Box Hill, Australia
  • Melbourne, Australia
  • Brussels, Belgium
  • Kortrijk, Belgium
  • Leuven, Belgium
  • Florianópolis, Brazil
  • Ijuí, Brazil
  • Porto Alegre, Brazil
  • São José do Rio Preto, Brazil
  • Sofia, Bulgaria
  • Calgary, Alberta, Canada
  • Toronto, CA, Canada
  • Greater Sudbury, Ontario, Canada
  • Newmarket, Ontario, Canada
  • Santiago, Chile
  • Olomouc, Czechia
  • Brest, France
  • + 86 more on CT.gov