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)

INTRODUCTION

  • Org Study ID: D910FC00001
  • Secondary ID: N/A
  • NTC ID: NCT04078152
  • Sponsor: 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.

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.


  • Overall Status
    Recruiting
  • Start Date
    September 5, 2019
  • Phase
    Phase 4
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0)

Primary Outcome 1 - Timeframe: Estimated to be up to 3 years

CONDITION

  • Solid Tumor

ELIGIBILITY


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

Gender: All

Minimum Age: 130 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jared Weiss, MD

Role: Principal Investigator

Affiliation: University of North Carolina, Chapel Hill

Overall Contact

Name: Jared Weiss, MD

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION

Facility Status Contact
Facility: Research Site
Fullerton, California 92835
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Augusta, Georgia 30912
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Baltimore, Maryland 21201
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Minneapolis, Minnesota 55407
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Saint Louis, Missouri 63110
United States
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Facility: Research Site
Mineola, New York 11501-4237
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Chapel Hill, North Carolina 27514
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Huntersville, North Carolina 28078
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Nashville, Tennessee 37203
United States
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Facility: Research Site
Dallas, Texas 75251
United States
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Facility: Research Site
Box Hill, 3128
Australia
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Facility: Research Site
Melbourne, 3000
Australia
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Facility: Research Site
Ijuí, 98700-000
Brazil
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Facility: Research Site
Sao Jose Rio Preto, 15090-000
Brazil
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Facility: Research Site
Calgary, Alberta T2N 4N2
Canada
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Facility: Research Site
Toronto, CA M5G 2M9
Canada
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Facility: Research Site
Newmarket, Ontario L3Y 2P9
Canada
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Facility: Research Site
Sudbury, Ontario P3E 5J1
Canada
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Facility: Research Site
Hannover, 30625
Germany
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Budapest, 1121
Hungary
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Facility: Research Site
Miskolc, 3529
Hungary
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Facility: Research Site
Haifa, 91096
Israel
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Facility: Research Site
Fukushima-shi, 960-1295
Japan
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Facility: Research Site
Hirakata-shi, 573-1191
Japan
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Facility: Research Site
Isehara-shi, 259-1193
Japan
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Facility: Research Site
Izumi-shi, 594-0073
Japan
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Facility: Research Site
Koto-ku, 135-8550
Japan
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Facility: Research Site
Nagaoka-shi, 940-2085
Japan
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Facility: Research Site
Natori-shi, 981-1293
Japan
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Facility: Research Site
Okayama-shi, 700-8558
Japan
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Facility: Research Site
Osaka-shi, 541-8567
Japan
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Facility: Research Site
Saga-shi, 840-8571
Japan
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Facility: Research Site
Sunto-gun, 411-8777
Japan
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Facility: Research Site
Tokushima-shi, 770-8503
Japan
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Facility: Research Site
Yokohama-shi, 241-8515
Japan
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Facility: Research Site
Daegu, 41931
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Gwangju, 61469
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Gyeongsangnam-do, 52727
Korea, Republic of
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Facility: Research Site
Seo-Gu, 49241
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Seongnam-si, 13620
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Research Site
Seoul, 06351
Korea, Republic of
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Facility: Research Site
Amsterdam, 1066 CX
Netherlands
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Arnhem, 6815 AD
Netherlands
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Bielsko-Biała, 43-300
Poland
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Łódź, 90-302
Poland
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Arkhangelsk, 163045
Russian Federation
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Moscow, 111123
Russian Federation
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Obninsk, 249036
Russian Federation
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Facility: Research Site
Omsk, 644013
Russian Federation
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Facility: Research Site
pos.Pesochnyi, 197758
Russian Federation
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Saint-Petersburg, 197022
Russian Federation
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Facility: Research Site
Saint-Petersburg, 197758
Russian Federation
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Facility: Research Site
Sremska Kamenica, 21204
Serbia
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Facility: Research Site
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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Madrid, 28007
Spain
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Madrid, 28034
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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Sevilla, 41013
Spain
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Valencia, 46015
Spain
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Valencia, 46026
Spain
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Lausanne, 1011
Switzerland
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New Taipei, 23561
Taiwan
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Taichung, 40447
Taiwan
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Facility: Research Site
Taichung, 40705
Taiwan
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Tainan, 704
Taiwan
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Facility: Research Site
Taipei, 11217
Taiwan
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Facility: Research Site
Bangkok, 10330
Thailand
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Facility: Research Site
Songkhla, 90110
Thailand
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Facility: Research Site
Chernivtsі, 58013
Ukraine
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Facility: Research Site
Dnipro, 49102
Ukraine
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Ivano-Frankivsk, 76018
Ukraine
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Kharkiv Region, 61070
Ukraine
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Kirovohrad, 25006
Ukraine
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Facility: Research Site
Kryvyi Rih, 50048
Ukraine
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Facility: Research Site
Kyiv, 03022
Ukraine
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Kyiv, 03115
Ukraine
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Kyiv, 8112
Ukraine
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Facility: Research Site
Uzhhorod, 88014
Ukraine
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Vinnytsia, 21029
Ukraine
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Facility: Research Site
Glasgow, G12 0YN
United Kingdom
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Facility: Research Site
London, EC1A 7BE
United Kingdom
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Facility: Research Site
Manchester, M20 4BX
United Kingdom
Status: Recruiting Contact: N/A