Clinical trial · Interventional
Durvalumab Long-Term Safety and Efficacy Study
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)
NCT04078152CI-TRIAL-00083994WAVEcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Durvalumab Monotherapy
- interventionNames
- Drug: Durvalumab
- type
- NO_INTERVENTION
- label
- Off Treatment
- description
- Follow up Only
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- 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
- description
- An AE was the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A SAE was an AE occurring during any study phase that fulfilled one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; was an important medical event that jeopardized the participant or required medical treatment to prevent one of the outcomes listed above.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.