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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04078152
Ethics application status
Date submitted
9/08/2019
Date registered
4/09/2019

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
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
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
Country [22] 0 0
Canada
State/province [22] 0 0
CA
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Chile
State/province [24] 0 0
Santiago
Country [25] 0 0
Czechia
State/province [25] 0 0
Olomouc
Country [26] 0 0
France
State/province [26] 0 0
Brest Cedex
Country [27] 0 0
France
State/province [27] 0 0
Lille
Country [28] 0 0
France
State/province [28] 0 0
Lyon Cedex 08
Country [29] 0 0
Germany
State/province [29] 0 0
Dresden
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Greece
State/province [31] 0 0
Holargos, Athens
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Miskolc
Country [34] 0 0
India
State/province [34] 0 0
Chennai
Country [35] 0 0
Israel
State/province [35] 0 0
Haifa
Country [36] 0 0
Japan
State/province [36] 0 0
Bunkyo-ku
Country [37] 0 0
Japan
State/province [37] 0 0
Fukushima-shi
Country [38] 0 0
Japan
State/province [38] 0 0
Isehara-shi
Country [39] 0 0
Japan
State/province [39] 0 0
Izumi-shi
Country [40] 0 0
Japan
State/province [40] 0 0
Kishiwada-shi
Country [41] 0 0
Japan
State/province [41] 0 0
Koto-ku
Country [42] 0 0
Japan
State/province [42] 0 0
Nagaoka-shi
Country [43] 0 0
Japan
State/province [43] 0 0
Nagoya-shi
Country [44] 0 0
Japan
State/province [44] 0 0
Natori-shi
Country [45] 0 0
Japan
State/province [45] 0 0
Okayama-shi
Country [46] 0 0
Japan
State/province [46] 0 0
Osaka-shi
Country [47] 0 0
Japan
State/province [47] 0 0
Saga-shi
Country [48] 0 0
Japan
State/province [48] 0 0
Suita-shi
Country [49] 0 0
Japan
State/province [49] 0 0
Sunto-gun
Country [50] 0 0
Japan
State/province [50] 0 0
Tokushima-shi
Country [51] 0 0
Japan
State/province [51] 0 0
Yokohama-shi
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Daegu
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Gwangju
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Gyeongsangnam-do
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seo-Gu
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seongnam-si
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seoul
Country [58] 0 0
Malaysia
State/province [58] 0 0
Kuching
Country [59] 0 0
Netherlands
State/province [59] 0 0
Amsterdam
Country [60] 0 0
Netherlands
State/province [60] 0 0
Arnhem
Country [61] 0 0
Poland
State/province [61] 0 0
Olsztyn
Country [62] 0 0
Poland
State/province [62] 0 0
Lódz
Country [63] 0 0
Romania
State/province [63] 0 0
Craiova
Country [64] 0 0
Romania
State/province [64] 0 0
Suceava
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Arkhangelsk
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Omsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
pos.Pesochnyi
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Saint-Petersburg
Country [70] 0 0
Serbia
State/province [70] 0 0
Sremska Kamenica
Country [71] 0 0
Spain
State/province [71] 0 0
Badalona
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
Country [73] 0 0
Spain
State/province [73] 0 0
Girona
Country [74] 0 0
Spain
State/province [74] 0 0
Jaén
Country [75] 0 0
Spain
State/province [75] 0 0
Madrid
Country [76] 0 0
Spain
State/province [76] 0 0
Marbella
Country [77] 0 0
Spain
State/province [77] 0 0
Málaga
Country [78] 0 0
Spain
State/province [78] 0 0
Valencia
Country [79] 0 0
Switzerland
State/province [79] 0 0
Bellinzona
Country [80] 0 0
Switzerland
State/province [80] 0 0
Lausanne
Country [81] 0 0
Taiwan
State/province [81] 0 0
New Taipei
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taichung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Tainan
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taipei
Country [85] 0 0
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
Country [92] 0 0
Ukraine
State/province [92] 0 0
Kirovohrad
Country [93] 0 0
Ukraine
State/province [93] 0 0
Kryvyi Rih
Country [94] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04078152