Solid TumorPhase 4WAVENCT04078152
Durvalumab Long-Term Safety and Efficacy Study
A Phase 4 study testing Durvalumab in people with Solid Tumor, run by AstraZeneca at 116 sites in 31 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 116 sitesin 31 countries
- Study dates
- 5 Sep 2019to 31 Oct 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The following exclusion criteria apply only to patients receiving treatment or retreatment:
- 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
Trial locations and contacts
116 sites in 31 countries.
116 sites in 31 countries
Japan16 sites
Research Site
Bunkyō City, 113-8677
Research Site
Fukushima, 960-1295
Research Site
Isehara-shi, 259-1193
Research Site
Izumi-shi, 594-0073
Research Site
Kishiwada-shi, 596-8501
Research Site
Kōtoku, 135-8550
Research Site
Nagaoka-shi, 940-2085
Research Site
Nagoya, 466-8560
Research Site
Natori-shi, 981-1293
Research Site
Okayama, 700-8558
Research Site
Osaka, 541-8567
Research Site
Saga, 840-8571
Research Site
Suita-shi, 565-0871
Research Site
Sunto-gun, 411-8777
Research Site
Tokushima, 770-8503
Research Site
Yokohama, 241-8515
United States12 sites
Research Site
Augusta, Georgia, 30912
Research Site
Baltimore, Maryland, 21201
Research Site
Chapel Hill, North Carolina, 27514
Research Site
Dallas, Texas, 75251
Research Site
Fullerton, California, 92835
Research Site
Greenville, South Carolina, 29605
Research Site
Huntersville, North Carolina, 28078
Research Site
Mineola, New York, 11501
Research Site
Minneapolis, Minnesota, 55407
Research Site
Nashville, Tennessee, 37203
Research Site
St Louis, Missouri, 63110
Research Site
Washington D.C., District of Columbia, 20007
Spain11 sites
Research Site
Badalona, 08916
Research Site
Barcelona, 08028
Research Site
Barcelona, 08035
Research Site
Barcelona, 08041
Research Site
Girona, 17007
Research Site
Jaén, 23007
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Málaga, 29010
Research Site
Marbella, 29600
Research Site
Valencia, 46026
Ukraine11 sites
Research Site
Chernivtsі, 58013
Research Site
Ivano-Frankivsk, 76018
Research Site
Kharkiv, 61070
Research Site
Kirovohrad, 25006
Research Site
Kryvyi Rih, 50048
Research Site
Kyiv, 03022
Research Site
Kyiv, 03115
Research Site
Kyiv, 8112
Research Site
Sumy, 40005
Research Site
Uzhhorod, 88014
Research Site
Vinnytsia, 21029
South Korea8 sites
Research Site
Daegu, 41931
Research Site
Gwangju, 61469
Research Site
Gyeongsangnam-do, 52727
Research Site
Seogu, 49241
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Russia7 sites
Research Site
Arkhangelsk, 163045
Research Site
Moscow, 111123
Research Site
Moscow, 115280
Research Site
Omsk, 644013
Research Site
pos.Pesochnyi, 197758
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197758
Taiwan5 sites
Research Site
New Taipei City, 23561
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Taipei, 11217
Brazil4 sites
Research Site
Florianópolis, 88034-000
Research Site
Ijuí, 98700-000
Research Site
Porto Alegre, 90035-903
Research Site
São José do Rio Preto, 15090-000
Canada4 sites
Research Site
Calgary, Alberta, T2N 4N2
Research Site
Greater Sudbury, Ontario, P3E 5J1
Research Site
Newmarket, Ontario, L3Y 2P9
Research Site
Toronto, CA, M5G 2M9
Belgium3 sites
Research Site
Brussels, 1090
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000
France3 sites
Research Site
Brest, 29609
Research Site
Lille, 59037
Research Site
Lyon, 69373
Poland3 sites
Research Site
Lodz, 90-302
Research Site
Lodz, 93-509
Research Site
Olsztyn, 10-357
United Kingdom3 sites
Research Site
London, EC1A 7BE
Research Site
London, WC1N 3BG
Research Site
Manchester, M20 4BX
Netherlands2 sites
Research Site
Amsterdam, 1066 CX
Research Site
Arnhem, 6815 AD
Switzerland2 sites
Research Site
Bellinzona, CH-6500
Research Site
Lausanne, 1011
Turkey (Türkiye)2 sites
Research Site
Adana, 01120
Research Site
Istanbul, 34098
About this study
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)
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.
Read the detailed 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.
- Conditions
- Solid Tumor
- Being tested
- Durvalumab
- Keywords
- non-small cell lung cancer (NSCLC), urothelial cancer, durvalumab, long-term safety, efficacy, overall survival, immunotherapy, checkpoint inhibitor, PD-L1, retreatment, Gastric adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
IV infusion q4w with 1500mg durvalumab until progressive disease
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Durvalumab Monotherapy Receives: Drug: Durvalumab |
| Off Treatment | No intervention | Follow up Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The ORR was defined as the percentage of participants with a confirmed investigator-assessed response of either complete response (CR) or partial response (PR) from the date of re-initiation of treatment with durvalumab monotherapy. Tumor assessments were performed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions (TLs) since baseline and reduction in short axis diameter to <10 millimeters (mm) for any pathological lymph nodes selected as TLs. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameter.
Measured: 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)
The DOR was defined as the time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. Tumor assessments were performed according to RECIST v1.1.
Measured: 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
Number of participants who were alive are reported in this outcome measure. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
Measured: Up to approximately 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start5 Sep 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Parexel, Medidata Solutions, CISCRP
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078152
- Sponsor's protocol ID
- D910FC00001
- Other IDs
- 2019-001402-20, 2019
- Acronym
- WAVE
- Status last verified
- Nov 2024
- First submitted
- 9 Aug 2019
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04078152
- Acronym / sponsor ID
- WAVE / D910FC00001
- Conditions
- Solid Tumor
- Keywords
- non-small cell lung cancer (NSCLC), urothelial cancer, durvalumab, long-term safety, efficacy, overall survival, immunotherapy, checkpoint inhibitor, PD-L1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Parexel, Medidata Solutions, CISCRP
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Posted 4 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: DurvalumabDurvalumab Monotherapy |
| Off Treatment | No intervention | –Follow up Only |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- The following exclusion criteria apply only to patients receiving treatment or retreatment:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736IV infusion q4w with 1500mg durvalumab until progressive disease | Drug | Treatment |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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
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.
3 secondary outcomes
Cohort 2: Overall Response Rate (ORR)
Time frame: 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)
Time frame: 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
Time frame: Up to approximately 37 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Weiss, MD principal investigator
University of North Carolina, Chapel Hill
116 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Durvalumab in people with Solid Tumor, run by AstraZeneca at 116 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in Japan, United States, Spain, Ukraine, South Korea and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.