Durvalumab Long-Term Safety and Efficacy Study (WAVE)

November 26, 2024 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Rosario, Argentina, S2000KZE
        • Research Site
  • Australia
      • Box Hill, Australia, 3128
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Kortrijk, Belgium, 8500
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Brazil
      • Florianópolis, Brazil, 88034-000
        • Research Site
      • Ijuí, Brazil, 98700-000
        • Research Site
      • Porto Alegre, Brazil, 90035-903
        • Research Site
      • Sao Jose Do Rio Preto, Brazil, 15090-000
        • Research Site
  • Bulgaria
      • Sofia, Bulgaria, 1612
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Research Site
    • CA
      • Toronto, CA, Canada, M5G 2M9
        • Research Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Research Site
      • Sudbury, Ontario, Canada, P3E 5J1
        • Research Site
  • Chile
      • Santiago, Chile, 7500000
        • Research Site
  • Czechia
      • Olomouc, Czechia, 775 20
        • Research Site
  • France
      • Brest Cedex, France, 29609
        • Research Site
      • Lille, France, 59037
        • Research Site
      • Lyon Cedex 08, France, 69373
        • Research Site
  • Germany
      • Dresden, Germany, 1307
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
  • Greece
      • Holargos, Athens, Greece, 155 62
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Miskolc, Hungary, 3526
        • Research Site
  • India
      • Chennai, India, 600006
        • Research Site
  • Israel
      • Haifa, Israel, 91096
        • Research Site
  • Japan
      • Bunkyo-ku, Japan, 113-8677
        • Research Site
      • Fukushima-shi, Japan, 960-1295
        • Research Site
      • Isehara-shi, Japan, 259-1193
        • Research Site
      • Izumi-shi, Japan, 594-0073
        • Research Site
      • Kishiwada-shi, Japan, 596-8501
        • Research Site
      • Koto-ku, Japan, 135-8550
        • Research Site
      • Nagaoka-shi, Japan, 940-2085
        • Research Site
      • Nagoya-shi, Japan, 466-8560
        • Research Site
      • Natori-shi, Japan, 981-1293
        • Research Site
      • Okayama-shi, Japan, 700-8558
        • Research Site
      • Osaka-shi, Japan, 541-8567
        • Research Site
      • Saga-shi, Japan, 840-8571
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Tokushima-shi, Japan, 770-8503
        • Research Site
      • Yokohama-shi, Japan, 241-8515
        • Research Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41931
        • Research Site
      • Gwangju, Korea, Republic of, 61469
        • Research Site
      • Gyeongsangnam-do, Korea, Republic of, 52727
        • Research Site
      • Seo-Gu, Korea, Republic of, 49241
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
  • Malaysia
      • Kuching, Malaysia, 93586
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Arnhem, Netherlands, 6815 AD
        • Research Site
  • Poland
      • Olsztyn, Poland, 10-357
        • Research Site
      • Łódź, Poland, 90-302
        • Research Site
      • Łódź, Poland, 93-509
        • Research Site
  • Romania
      • Craiova, Romania, 200347
        • Research Site
      • Suceava, Romania, 720237
        • Research Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Research Site
      • Moscow, Russian Federation, 111123
        • Research Site
      • Moscow, Russian Federation, 115280
        • Research Site
      • Omsk, Russian Federation, 644013
        • Research Site
      • Saint-Petersburg, Russian Federation, 197758
        • Research Site
      • Saint-Petersburg, Russian Federation, 197022
        • Research Site
      • pos.Pesochnyi, Russian Federation, 197758
        • Research Site
  • Serbia
      • Sremska Kamenica, Serbia, 21204
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08028
        • Research Site
      • Barcelona, Spain, 08041
        • Research Site
      • Girona, Spain, 17007
        • Research Site
      • Jaén, Spain, 23007
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Marbella, Spain, 29600
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
  • Switzerland
      • Bellinzona, Switzerland, CH-6500
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
  • Taiwan
      • New Taipei, Taiwan, 23561
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Research Site
      • Songkhla, Thailand, 90110
        • Research Site
  • Turkey
      • Adana, Turkey, 01120
        • Research Site
      • Istanbul, Turkey, 34098
        • Research Site
  • Ukraine
      • Chernivtsі, Ukraine, 58013
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Research Site
      • Kharkiv, Ukraine, 61070
        • Research Site
      • Kirovohrad, Ukraine, 25006
        • Research Site
      • Kryvyi Rih, Ukraine, 50048
        • Research Site
      • Kyiv, Ukraine, 03115
        • Research Site
      • Kyiv, Ukraine, 03022
        • Research Site
      • Kyiv, Ukraine, 8112
        • Research Site
      • Sumy, Ukraine, 40005
        • Research Site
      • Uzhhorod, Ukraine, 88014
        • Research Site
      • Vinnytsia, Ukraine, 21029
        • Research Site
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Research Site
      • London, United Kingdom, WC1N 3BG
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • New York
      • Mineola, New York, United States, 11501
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Research Site
      • Huntersville, North Carolina, United States, 28078
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75251
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Durvalumab Monotherapy
Drug: Durvalumab
IV infusion q4w with 1500mg durvalumab until progressive disease
Other Names:
  • MEDI4736
No Intervention: Off Treatment
Follow up Only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
Up to approximately 37 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parexel
IQVIA Pty Ltd
Medidata Solutions
CISCRP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jared Weiss, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D910FC00001
  • 2019-001402-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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