Durvalumab Long-Term Safety and Efficacy Study (WAVE)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Solid Tumor

Treatments: Drug: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04078152

D910FC00001

2019-001402-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

Treatment

Experimental group

Description:

Durvalumab Monotherapy

Treatment:

Drug: Durvalumab

Off Treatment

No Intervention group

Description:

Follow up Only