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)

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: Active, not recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Durvalumab

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: Interventional
• Enrollment (Actual): 163
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of durvalumab in terms of Overall Response Rate (ORR) in patients who undergo retreatment with durvalumab	The analysis of ORR will be based on investigator assessments using RECIST 1.1	3 years
Efficacy of durvalumab in terms of Duration of Response (DOR) in patients who undergo retreatment with durvalumab	The analysis of DOR will be based on investigator assessments using RECIST 1.1	3 years
Overall Survival (OS)	Assessments of Overall Survival will be made at periodic time points until death	3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel; Iqvia Pty Ltd; Medidata Solutions; CISCRP
• Investigators: Principal Investigator: Jared Weiss, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: immunotherapy; PD-L1; urothelial cancer; Gastric adenocarcinoma; overall survival; checkpoint inhibitor; durvalumab; non-small cell lung cancer (NSCLC); long-term safety, efficacy; retreatment
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab
• Other Study ID 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