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.
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
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | MEDI4736 | Treatment |
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
Name | Type | Description | Interventions |
---|
Treatment | Experimental | Durvalumab Monotherapy | |
Off Treatment | No Intervention | Follow 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: | 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
August 23, 2021