Durvalumab Long-Term Safety and Efficacy Study

Part of paid clinical trials in Fullerton, California.

Sponsor
AstraZeneca
Study ID
NCT04078152
Phase
PHASE4
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    IV infusion q4w with 1500mg durvalumab until progressive disease

Study Details

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 Dates

Start date
Sep 5, 2019
Status verified
Nov 2024
Primary completion
Oct 31, 2022
Completion
Oct 31, 2024

Study Design

Enrollment
163 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Durvalumab Monotherapy
  • No Intervention: Off Treatment
    Follow up Only

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteFullertonCalifornia92835-
Research SiteWashington D.C.District of Columbia20007-
Research SiteAugustaGeorgia30912-
Research SiteBaltimoreMaryland21201-
Research SiteMinneapolisMinnesota55407-
Research SiteSt LouisMissouri63110-
Research SiteMineolaNew York11501-
Research SiteChapel HillNorth Carolina27514-
Research SiteHuntersvilleNorth Carolina28078-
Research SiteGreenvilleSouth Carolina29605-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75251-

Find similar trials in Fullerton, CA

By research site
Research Site· Fullerton, CAResearch Site· Washington D.C., DCResearch Site· Augusta, GAResearch Site· Baltimore, MDResearch Site· Minneapolis, MNResearch Site· St Louis, MO

Related Studies