Durvalumab Long-Term Safety and Efficacy Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Durvalumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Durvalumab Monotherapy | Drug: Durvalumab<br>* IV infusion q4w with 1500mg durvalumab until progressive disease<br>* Other names: MEDI4736;|
| No Intervention: Off Treatment<br>Follow up Only | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer (NSCLC), urothelial cancer, durvalumab, long-term safety, efficacy, overall survival, immunotherapy, checkpoint inhibitor, PD-L1, retreatment, Gastric adenocarcinoma