Durvalumab Long-Term Safety and Efficacy Study
WAVE
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)
2 other identifiers
interventional
163
31 countries
116
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2019
Longer than P75 for phase_4
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedStudy Start
First participant enrolled
September 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedResults Posted
Study results publicly available
September 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedDecember 20, 2024
November 1, 2024
3.2 years
August 9, 2019
August 13, 2024
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A SAE was an AE occurring during any study phase that fulfilled one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; was an important medical event that jeopardized the participant or required medical treatment to prevent one of the outcomes listed above.
From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months
Secondary Outcomes (3)
Cohort 2: Overall Response Rate (ORR)
Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
Cohort 2: Duration of Response (DOR)
Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
Number of Participants Who Were Alive
Up to approximately 37 months
Study Arms (2)
Treatment
EXPERIMENTALDurvalumab Monotherapy
Off Treatment
NO INTERVENTIONFollow up Only
Interventions
IV infusion q4w with 1500mg durvalumab until progressive disease
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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).
- Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.
You may not qualify if:
- 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
- Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
- Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study
- Diagnosis of a new primary malignancy since enrollment into the parent clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Iqvia Pty Ltdcollaborator
- Parexelcollaborator
- Medidata Solutionscollaborator
- CISCRPcollaborator
Study Sites (116)
Research Site
Fullerton, California, 92835, United States
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Washington D.C., District of Columbia, 20007, United States
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Augusta, Georgia, 30912, United States
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Baltimore, Maryland, 21201, United States
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Minneapolis, Minnesota, 55407, United States
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St Louis, Missouri, 63110, United States
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Mineola, New York, 11501, United States
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Chapel Hill, North Carolina, 27514, United States
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Huntersville, North Carolina, 28078, United States
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Greenville, South Carolina, 29605, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75251, United States
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Rosario, S2000KZE, Argentina
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Box Hill, 3128, Australia
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Melbourne, 3000, Australia
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Brussels, 1090, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Florianópolis, 88034-000, Brazil
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Ijuí, 98700-000, Brazil
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Porto Alegre, 90035-903, Brazil
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São José do Rio Preto, 15090-000, Brazil
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Sofia, 1612, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Toronto, CA, M5G 2M9, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Santiago, 7500000, Chile
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Olomouc, 775 20, Czechia
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Brest, 29609, France
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Lille, 59037, France
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Lyon, 69373, France
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Dresden, 1307, Germany
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Hanover, 30625, Germany
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Holargos, Athens, 155 62, Greece
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Budapest, 1121, Hungary
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Miskolc, 3526, Hungary
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Chennai, 600006, India
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Haifa, 91096, Israel
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Bunkyō City, 113-8677, Japan
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Fukushima, 960-1295, Japan
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Isehara-shi, 259-1193, Japan
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Izumi-shi, 594-0073, Japan
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Kishiwada-shi, 596-8501, Japan
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Kōtoku, 135-8550, Japan
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Nagaoka-shi, 940-2085, Japan
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Nagoya, 466-8560, Japan
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Natori-shi, 981-1293, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Saga, 840-8571, Japan
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Suita-shi, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Tokushima, 770-8503, Japan
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Yokohama, 241-8515, Japan
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Kuching, 93586, Malaysia
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Amsterdam, 1066 CX, Netherlands
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Arnhem, 6815 AD, Netherlands
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Lodz, 90-302, Poland
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Lodz, 93-509, Poland
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Olsztyn, 10-357, Poland
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Craiova, 200347, Romania
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Suceava, 720237, Romania
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Arkhangelsk, 163045, Russia
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Moscow, 111123, Russia
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Moscow, 115280, Russia
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Omsk, 644013, Russia
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pos.Pesochnyi, 197758, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Kamenitz, 21204, Serbia
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Daegu, 41931, South Korea
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Gwangju, 61469, South Korea
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Gyeongsangnam-do, 52727, South Korea
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Seogu, 49241, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Badalona, 08916, Spain
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Barcelona, 08028, Spain
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Barcelona, 08035, Spain
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Barcelona, 08041, Spain
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Girona, 17007, Spain
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Jaén, 23007, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Marbella, 29600, Spain
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Málaga, 29010, Spain
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Valencia, 46026, Spain
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Bellinzona, CH-6500, Switzerland
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Lausanne, 1011, Switzerland
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New Taipei City, 23561, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 11217, Taiwan
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Bangkok, 10330, Thailand
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Songkhla, 90110, Thailand
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Adana, 01120, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Chernivtsі, 58013, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv, 61070, Ukraine
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Kirovohrad, 25006, Ukraine
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Kryvyi Rih, 50048, Ukraine
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Kyiv, 03022, Ukraine
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Kyiv, 03115, Ukraine
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Kyiv, 8112, Ukraine
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Sumy, 40005, Ukraine
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Uzhhorod, 88014, Ukraine
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Vinnytsia, 21029, Ukraine
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London, EC1A 7BE, United Kingdom
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London, WC1N 3BG, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Hanoi, 100000, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Jared Weiss, MD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- All involved know the identity of the intervention assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2019
First Posted
September 4, 2019
Study Start
September 5, 2019
Primary Completion
October 31, 2022
Study Completion
October 31, 2024
Last Updated
December 20, 2024
Results First Posted
September 4, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.