Clinical Trials /

Durvalumab Long-Term Safety and Efficacy Study

NCT04078152

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Durvalumab Long-Term Safety and Efficacy Study
  • Official Title: An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who Are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

Clinical Trial IDs

  • ORG STUDY ID: D910FC00001
  • NCT ID: NCT04078152

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
DurvalumabMEDI4736Treatment

Purpose

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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions
TreatmentExperimentalDurvalumab Monotherapy
  • Durvalumab
Off TreatmentNo InterventionFollow up Only

    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
          
    Maximum Eligible Age:130 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0)
    Time Frame:Estimated to be up to 3 years
    Safety Issue:
    Description:Type, frequency and severity of adverse events (including those treatment and post-treatment periods) will be listed according to CTCAE v5.0

    Secondary Outcome Measures

    Measure:Efficacy of durvalumab in terms of Overall Response Rate (ORR) in patients who undergo retreatment with durvalumab
    Time Frame:3 years
    Safety Issue:
    Description:The analysis of ORR will be based on investigator assessments using RECIST 1.1
    Measure:Efficacy of durvalumab in terms of Duration of Response (DOR) in patients who undergo retreatment with durvalumab
    Time Frame:3 years
    Safety Issue:
    Description:The analysis of DOR will be based on investigator assessments using RECIST 1.1
    Measure:Overall Survival (OS)
    Time Frame:3 years
    Safety Issue:
    Description:Assessments of Overall Survival will be made at periodic time points until death

    Details

    Phase:Phase 4
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:AstraZeneca

    Trial Keywords

    • non-small cell lung cancer (NSCLC)
    • urothelial cancer
    • durvalumab
    • long-term safety, efficacy
    • overall survival
    • immunotherapy
    • checkpoint inhibitor
    • PD-L1
    • retreatment
    • Gastric adenocarcinoma

    Last Updated