Durvalumab Long-Term Safety and Efficacy Study

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    219
  • sponsor
    AstraZeneca
Updated on 22 September 2021
cancer treatment
antineoplastic

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) information.

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 with any other approved or investigational anticancer agents, in an eligible AstraZeneca/MedImmune-sponsored clinical study.

Details
Condition Solid Tumors, Solid Tumor, Solid Neoplasm, Solid Tumour
Treatment durvalumab
Clinical Study IdentifierNCT04078152
SponsorAstraZeneca
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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