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Durvalumab Long-Term Safety and Efficacy Study (WAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04078152
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Iqvia Pty Ltd
Parexel
Medidata Solutions
CISCRP
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Durvalumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: All involved know the identity of the intervention assignment.
Primary Purpose: Treatment
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)
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Treatment
Durvalumab Monotherapy
Drug: Durvalumab
IV infusion q4w with 1500mg durvalumab until progressive disease
Other Name: MEDI4736

No Intervention: Off Treatment
Follow up Only



Primary Outcome Measures :
  1. Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0) [ Time Frame: Estimated to be up to 3 years ]
    Type, frequency and severity of adverse events (including those treatment and post-treatment periods) will be listed according to CTCAE v5.0


Secondary Outcome Measures :
  1. Efficacy of durvalumab in terms of Overall Response Rate (ORR) in patients who undergo retreatment with durvalumab [ Time Frame: 3 years ]
    The analysis of ORR will be based on investigator assessments using RECIST 1.1

  2. Efficacy of durvalumab in terms of Duration of Response (DOR) in patients who undergo retreatment with durvalumab [ Time Frame: 3 years ]
    The analysis of DOR will be based on investigator assessments using RECIST 1.1

  3. Overall Survival (OS) [ Time Frame: 3 years ]
    Assessments of Overall Survival will be made at periodic time points until death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078152


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 148 study locations
Sponsors and Collaborators
AstraZeneca
Iqvia Pty Ltd
Parexel
Medidata Solutions
CISCRP
Investigators
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Principal Investigator: Jared Weiss, MD University of North Carolina, Chapel Hill

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04078152    
Other Study ID Numbers: D910FC00001
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
non-small cell lung cancer (NSCLC)
urothelial cancer
durvalumab
long-term safety, efficacy
overall survival
immunotherapy
checkpoint inhibitor
PD-L1
retreatment
Gastric adenocarcinoma
Additional relevant MeSH terms:
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Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents