Durvalumab Long-Term Safety and Efficacy Study

Solid Tumor Clinical Trial

— WAVE  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04078152
• Other study ID #: D910FC00001
• Secondary ID: 2019-001402-20
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 5, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• Durvalumab
IV infusion q4w with 1500mg durvalumab until progressive disease

Locations

Country	Name	City	State
Argentina	Research Site	Rosario
Australia	Research Site	Box Hill
Australia	Research Site	Melbourne
Belgium	Research Site	Brussels
Belgium	Research Site	Kortrijk
Belgium	Research Site	Leuven
Brazil	Research Site	Florianópolis
Brazil	Research Site	Ijuí
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Sao Jose Do Rio Preto
Bulgaria	Research Site	Sofia
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Toronto	CA
Chile	Research Site	Santiago
Czechia	Research Site	Olomouc
France	Research Site	Brest Cedex
France	Research Site	Lille
France	Research Site	Lyon Cedex 08
Germany	Research Site	Dresden
Germany	Research Site	Hannover
Greece	Research Site	Holargos, Athens
Hungary	Research Site	Budapest
Hungary	Research Site	Miskolc
India	Research Site	Chennai
Israel	Research Site	Haifa
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Fukushima-shi
Japan	Research Site	Isehara-shi
Japan	Research Site	Izumi-shi
Japan	Research Site	Kishiwada-shi
Japan	Research Site	Koto-ku
Japan	Research Site	Nagaoka-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Natori-shi
Japan	Research Site	Okayama-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Saga-shi
Japan	Research Site	Suita-shi
Japan	Research Site	Sunto-gun
Japan	Research Site	Tokushima-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Gyeongsangnam-do
Korea, Republic of	Research Site	Seo-Gu
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Malaysia	Research Site	Kuching
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Poland	Research Site	Lódz
Poland	Research Site	Lódz
Poland	Research Site	Olsztyn
Romania	Research Site	Craiova
Romania	Research Site	Suceava
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	pos.Pesochnyi
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Serbia	Research Site	Sremska Kamenica
Spain	Research Site	Badalona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Girona
Spain	Research Site	Jaén
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Marbella
Spain	Research Site	Valencia
Switzerland	Research Site	Bellinzona
Switzerland	Research Site	Lausanne
Taiwan	Research Site	New Taipei
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Thailand	Research Site	Bangkok
Thailand	Research Site	Songkhla
Turkey	Research Site	Adana
Turkey	Research Site	Istanbul
Ukraine	Research Site	Chernivts?
Ukraine	Research Site	Ivano-Frankivsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kirovohrad
Ukraine	Research Site	Kryvyi Rih
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Sumy
Ukraine	Research Site	Uzhhorod
Ukraine	Research Site	Vinnytsia
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United States	Research Site	Augusta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Dallas	Texas
United States	Research Site	Fullerton	California
United States	Research Site	Greenville	South Carolina
United States	Research Site	Huntersville	North Carolina
United States	Research Site	Mineola	New York
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Nashville	Tennessee
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Washington	District of Columbia
Vietnam	Research Site	Hanoi

Sponsors (5)

Lead Sponsor	Collaborator
AstraZeneca	CISCRP, Iqvia Pty Ltd, Medidata Solutions, Parexel

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Overall Survival (OS)	Assessments of Overall Survival will be made at periodic time points until death	3 years