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) - WAVE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001402-20-DE

Enrollment

600

Registered

2019-10-31

Start date

2020-02-21

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Various types of cancer ( dependent on parent study) MedDRA version: 21.0 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 100000004864

Interventions

Product Name: Durvalumab Product Code: MEDI4736 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patient must be 18 years or older, at the time of signing the ICF. For subjects aged =65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To monitor long-term safety of durvalumab;Secondary Objective: -To assess the efficacy of durvalumab in terms of overall response rate (ORR) and duration of response (DOR) in patients who undergo retreatment with durvalumab -To assess the overall survival (OS) of patients;Primary end point(s): -All serious adverse events (SAEs) -Non-serious adverse events (AEs) that lead to dose modification, drug discontinuation, or withdrawal from the study -All Grade 3 and Grade 4 adverse events (AEs) -Grade 2 adverse events (AEs) that affect vital organs (eg, heart, liver) -Immune-mediated adverse events (AEs) -Laboratory findings qualifying as an serious adverse events/adverse events (SAE/AE);Timepoint(s) of evaluation of this end point: Various time points trough the study	—

Measure

Time frame

Main Objective: To monitor long-term safety of durvalumab;Secondary Objective: -To assess the efficacy of durvalumab in terms of overall response rate (ORR) and duration of response (DOR) in patients who undergo retreatment with durvalumab -To assess the overall survival (OS) of patients;Primary end point(s): -All serious adverse events (SAEs) -Non-serious adverse events (AEs) that lead to dose modification, drug discontinuation, or withdrawal from the study -All Grade 3 and Grade 4 adverse events (AEs) -Grade 2 adverse events (AEs) that affect vital organs (eg, heart, liver) -Immune-mediated adverse events (AEs) -Laboratory findings qualifying as an serious adverse events/adverse events (SAE/AE);Timepoint(s) of evaluation of this end point: Various time points trough the study

—

Secondary

Measure	Time frame
Secondary end point(s): -Overall response rate (ORR): percentage of patients with a confirmed response of CR or PR. -Duration of response (DOR): Time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. -Overall survival (OS):Time from date of randomization/enrollment in the parent clinical study until the date of death by any cause.;Timepoint(s) of evaluation of this end point: Various time points trough the study	—

Measure

Time frame

Secondary end point(s): -Overall response rate (ORR): percentage of patients with a confirmed response of CR or PR. -Duration of response (DOR): Time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. -Overall survival (OS):Time from date of randomization/enrollment in the parent clinical study until the date of death by any cause.;Timepoint(s) of evaluation of this end point: Various time points trough the study

—

Countries

Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States, Viet Nam

Contacts

Public ContactInformation Center

AstraZeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026