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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04078152




Registration number
NCT04078152
Ethics application status
Date submitted
9/08/2019
Date registered
4/09/2019
Date last updated
5/02/2024

Titles & IDs
Public title
Durvalumab Long-Term Safety and Efficacy Study
Scientific 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)
Secondary ID [1] 0 0
2019-001402-20
Secondary ID [2] 0 0
D910FC00001
Universal Trial Number (UTN)
Trial acronym
WAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab

Experimental: Treatment - Durvalumab Monotherapy

No Intervention: Off Treatment - Follow up Only


Treatment: Drugs: Durvalumab
IV infusion q4w with 1500mg durvalumab until progressive disease
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0)
Timepoint [1] 0 0
Estimated to be up to 3 years
Secondary outcome [1] 0 0
Efficacy of durvalumab in terms of Overall Response Rate (ORR) in patients who undergo retreatment with durvalumab
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Efficacy of durvalumab in terms of Duration of Response (DOR) in patients who undergo retreatment with durvalumab
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
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United States of America
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South Carolina
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United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Rosario
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Kortrijk
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Brazil
State/province [16] 0 0
Florianópolis
Country [17] 0 0
Brazil
State/province [17] 0 0
Ijuí
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Jose Do Rio Preto
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
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Canada
State/province [22] 0 0
CA
Country [23] 0 0
Canada
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Ontario
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Chile
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Santiago
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Czechia
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Olomouc
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France
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Brest Cedex
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France
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Lille
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France
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Lyon Cedex 08
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Germany
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Dresden
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Germany
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Hannover
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Greece
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Holargos, Athens
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Hungary
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Budapest
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Hungary
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Miskolc
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India
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Chennai
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Israel
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Haifa
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Japan
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Bunkyo-ku
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Japan
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Fukushima-shi
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Japan
State/province [38] 0 0
Isehara-shi
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Japan
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Izumi-shi
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Japan
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Kishiwada-shi
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Japan
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Koto-ku
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Japan
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Nagaoka-shi
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Japan
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Nagoya-shi
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Japan
State/province [44] 0 0
Natori-shi
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Japan
State/province [45] 0 0
Okayama-shi
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Japan
State/province [46] 0 0
Osaka-shi
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Japan
State/province [47] 0 0
Saga-shi
Country [48] 0 0
Japan
State/province [48] 0 0
Suita-shi
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Japan
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Sunto-gun
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Japan
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Tokushima-shi
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Japan
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Yokohama-shi
Country [52] 0 0
Korea, Republic of
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Daegu
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Korea, Republic of
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Gwangju
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Korea, Republic of
State/province [54] 0 0
Gyeongsangnam-do
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Korea, Republic of
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Seo-Gu
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Korea, Republic of
State/province [56] 0 0
Seongnam-si
Country [57] 0 0
Korea, Republic of
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Seoul
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Malaysia
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Kuching
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Poland
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Olsztyn
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Poland
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Lódz
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Romania
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Craiova
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Romania
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Suceava
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Russian Federation
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Arkhangelsk
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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pos.Pesochnyi
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Russian Federation
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Saint-Petersburg
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Serbia
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Sremska Kamenica
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Jaén
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Spain
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Madrid
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Spain
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Marbella
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Spain
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Málaga
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Spain
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Valencia
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Switzerland
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Bellinzona
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Switzerland
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Lausanne
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Taiwan
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New Taipei
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
State/province [85] 0 0
Bangkok
Country [86] 0 0
Thailand
State/province [86] 0 0
Songkhla
Country [87] 0 0
Turkey
State/province [87] 0 0
Adana
Country [88] 0 0
Turkey
State/province [88] 0 0
Istanbul
Country [89] 0 0
Ukraine
State/province [89] 0 0
Chernivts?
Country [90] 0 0
Ukraine
State/province [90] 0 0
Ivano-Frankivsk
Country [91] 0 0
Ukraine
State/province [91] 0 0
Kharkiv
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Ukraine
State/province [92] 0 0
Kirovohrad
Country [93] 0 0
Ukraine
State/province [93] 0 0
Kryvyi Rih
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Ukraine
State/province [94] 0 0
Kyiv
Country [95] 0 0
Ukraine
State/province [95] 0 0
Sumy
Country [96] 0 0
Ukraine
State/province [96] 0 0
Uzhhorod
Country [97] 0 0
Ukraine
State/province [97] 0 0
Vinnytsia
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Manchester
Country [100] 0 0
Vietnam
State/province [100] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Parexel
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Medidata Solutions
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
CISCRP
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04078152
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jared Weiss, MD
Address 0 0
University of North Carolina, Chapel Hill
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04078152