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BRIEF 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)

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)


  • Org Study ID: D910FC00001
  • Secondary ID:
  • NCT ID: NCT04078152
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting September 5, 2019 Phase 4 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 - Time Frame: Estimated to be up to 3 years

Condition:

  • Solid Tumor

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

Official Information

Name: Jared Weiss, MD

Role: Principal Investigator

Affiliation: University of North Carolina, Chapel Hill

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Anaheim, California 92801
United States
Withdrawn
Research Site
Fullerton, California 92835
United States
Recruiting
Research Site
La Jolla, California 92037
United States
Not yet recruiting
Research Site
San Francisco, California 94158
United States
Not yet recruiting
Research Site
South Pasadena, California 91030
United States
Not yet recruiting
Research Site
Washington, District of Columbia 20007
United States
Withdrawn
Research Site
Orlando, Florida 32806
United States
Withdrawn
Research Site
Tampa, Florida 33612
United States
Withdrawn
Research Site
Augusta, Georgia 30912
United States
Recruiting
Research Site
Chicago, Illinois 60637
United States
Withdrawn
Research Site
Baltimore, Maryland 21201
United States
Recruiting
Research Site
Baltimore, Maryland 21231
United States
Not yet recruiting
Research Site
Edina, Minnesota 55432
United States
Withdrawn
Research Site
Minneapolis, Minnesota 55407
United States
Recruiting
Research Site
Saint Louis, Missouri 63110
United States
Recruiting
Research Site
Mineola, New York 11501-4237
United States
Recruiting
Research Site
New York, New York 10022
United States
Withdrawn
Research Site
Chapel Hill, North Carolina 27514
United States
Recruiting
Research Site
Huntersville, North Carolina 28078
United States
Recruiting
Research Site
Cleveland, Ohio 44106
United States
Withdrawn
Research Site
Pittsburgh, Pennsylvania 15212
United States
Not yet recruiting
Research Site
Greenville, South Carolina 29605
United States
Recruiting
Research Site
Nashville, Tennessee 37203
United States
Recruiting
Research Site
Dallas, Texas 75251
United States
Recruiting
Research Site
Box Hill, 3128
Australia
Recruiting
Research Site
Clayton, 3168
Australia
Not yet recruiting
Research Site
Melbourne, 3000
Australia
Recruiting
Research Site
Melbourne, 3004
Australia
Withdrawn
Research Site
Southport, 4215
Australia
Not yet recruiting
Research Site
Brussels, 1090
Belgium
Not yet recruiting
Research Site
Kortrijk, 8500
Belgium
Not yet recruiting
Research Site
Leuven, 3000
Belgium
Not yet recruiting
Research Site
Liège, 4000
Belgium
Not yet recruiting
Research Site
Florianópolis, 88034-000
Brazil
Not yet recruiting
Research Site
Ijuí, 98700-000
Brazil
Recruiting
Research Site
Porto Alegre, 91350-200
Brazil
Withdrawn
Research Site
Rio de Janeiro, 22793-080
Brazil
Not yet recruiting
Research Site
Sao Jose Rio Preto, 15090-000
Brazil
Recruiting
Research Site
Calgary, Alberta T2N 4N2
Canada
Not yet recruiting
Research Site
Toronto, CA M5G 2M9
Canada
Recruiting
Research Site
Newmarket, Ontario L3Y 2P9
Canada
Recruiting
Research Site
Sudbury, Ontario P3E 5J1
Canada
Recruiting
Research Site
Quebec, G1R 2J6
Canada
Not yet recruiting
Research Site
Santiago, 7500000
Chile
Not yet recruiting
Research Site
Olomouc, 775 20
Czechia
Not yet recruiting
Research Site
Bordeaux cedex, 33075
France
Not yet recruiting
Research Site
Brest Cedex, 29609
France
Not yet recruiting
Research Site
Lille, 59037
France
Not yet recruiting
Research Site
Lyon Cedex 08, 69373
France
Not yet recruiting
Research Site
Marseille, 13915
France
Not yet recruiting
Research Site
Villejuif Cedex, 94805
France
Not yet recruiting
Research Site
Berlin, 12351
Germany
Withdrawn
Research Site
Dresden, 1307
Germany
Not yet recruiting
Research Site
Gauting, 82131
Germany
Not yet recruiting
Research Site
Hamburg, 20251
Germany
Not yet recruiting
Research Site
Hannover, 30625
Germany
Not yet recruiting
Research Site
Heidelberg, 69126
Germany
Not yet recruiting
Research Site
Hemer, 58675
Germany
Withdrawn
Research Site
Wuerzburg, 97070
Germany
Not yet recruiting
Research Site
Holargos, Athens, 155 62
Greece
Not yet recruiting
Research Site
Budapest, 1121
Hungary
Recruiting
Research Site
Budapest, 1121
Hungary
Withdrawn
Research Site
Budapest, 1122
Hungary
Withdrawn
Research Site
Miskolc, 3529
Hungary
Recruiting
Research Site
Haifa, 91096
Israel
Recruiting
Research Site
Milano, 20133
Italy
Not yet recruiting
Research Site
Padova, 35128
Italy
Not yet recruiting
Research Site
Saronno, 21047
Italy
Not yet recruiting
Research Site
Siena, 53100
Italy
Not yet recruiting
Research Site
Bunkyo-ku, 113-8677
Japan
Not yet recruiting
Research Site
Fukushima-shi, 960-1295
Japan
Recruiting
Research Site
Hirakata-shi, 573-1191
Japan
Recruiting
Research Site
Isehara-shi, 259-1193
Japan
Recruiting
Research Site
Izumi-shi, 594-0073
Japan
Recruiting
Research Site
Kishiwada-shi, 596-8501
Japan
Terminated
Research Site
Koto-ku, 135-8550
Japan
Recruiting
Research Site
Nagaoka-shi, 940-2085
Japan
Recruiting
Research Site
Nagoya-shi, 466-8560
Japan
Not yet recruiting
Research Site
Natori-shi, 981-1293
Japan
Recruiting
Research Site
Okayama-shi, 700-8558
Japan
Recruiting
Research Site
Osaka-shi, 541-8567
Japan
Recruiting
Research Site
Saga-shi, 840-8571
Japan
Recruiting
Research Site
Sunto-gun, 411-8777
Japan
Recruiting
Research Site
Tokushima-shi, 770-8503
Japan
Recruiting
Research Site
Yokohama-shi, 241-8515
Japan
Recruiting
Research Site
Daegu, 41931
Korea, Republic of
Recruiting
Research Site
Gwangju, 61469
Korea, Republic of
Recruiting
Research Site
Gyeongsangnam-do, 52727
Korea, Republic of
Recruiting
Research Site
Incheon, 405-760
Korea, Republic of
Not yet recruiting
Research Site
Seo-Gu, 49241
Korea, Republic of
Recruiting
Research Site
Seongnam-si, 13620
Korea, Republic of
Recruiting
Research Site
Seoul, 03080
Korea, Republic of
Recruiting
Research Site
Seoul, 03722
Korea, Republic of
Recruiting
Research Site
Seoul, 05505
Korea, Republic of
Not yet recruiting
Research Site
Seoul, 06351
Korea, Republic of
Recruiting
Research Site
Amsterdam, 1066 CX
Netherlands
Recruiting
Research Site
Arnhem, 6815 AD
Netherlands
Recruiting
Research Site
Bielsko-Biała, 43-300
Poland
Recruiting
Research Site
Łódź, 90-302
Poland
Not yet recruiting
Research Site
Łódź, 93-509
Poland
Not yet recruiting
Research Site
Craiova, 200347
Romania
Not yet recruiting
Research Site
Suceava, 720237
Romania
Not yet recruiting
Research Site
Arkhangelsk, 163045
Russian Federation
Recruiting
Research Site
Moscow, 105229
Russian Federation
Not yet recruiting
Research Site
Moscow, 111123
Russian Federation
Recruiting
Research Site
Obninsk, 249036
Russian Federation
Recruiting
Research Site
Omsk, 644013
Russian Federation
Recruiting
Research Site
pos.Pesochnyi, 197758
Russian Federation
Recruiting
Research Site
Saint-Petersburg, 197022
Russian Federation
Recruiting
Research Site
Saint-Petersburg, 197758
Russian Federation
Recruiting
Research Site
St.-Petersburg, 197089
Russian Federation
Not yet recruiting
Research Site
Sremska Kamenica, 21204
Serbia
Not yet recruiting
Research Site
Badalona, 08916
Spain
Recruiting
Research Site
Barcelona, 08028
Spain
Recruiting
Research Site
Barcelona, 08035
Spain
Recruiting
Research Site
Barcelona, 08036
Spain
Not yet recruiting
Research Site
Barcelona, 08041
Spain
Recruiting
Research Site
Girona, 17007
Spain
Recruiting
Research Site
Jaén, 23007
Spain
Recruiting
Research Site
Madrid, 28007
Spain
Recruiting
Research Site
Madrid, 28034
Spain
Recruiting
Research Site
Madrid, 28041
Spain
Recruiting
Research Site
Madrid, 28046
Spain
Recruiting
Research Site
Madrid, 28050
Spain
Withdrawn
Research Site
Marbella, 29600
Spain
Recruiting
Research Site
Málaga, 29010
Spain
Recruiting
Research Site
Sevilla, 41013
Spain
Recruiting
Research Site
Valencia, 46015
Spain
Recruiting
Research Site
Valencia, 46026
Spain
Recruiting
Research Site
Bellinzona, CH-6500
Switzerland
Not yet recruiting
Research Site
Lausanne, 1011
Switzerland
Not yet recruiting
Research Site
Kaohsiung, 83301
Taiwan
Withdrawn
Research Site
New Taipei, 23561
Taiwan
Recruiting
Research Site
Taichung, 40447
Taiwan
Recruiting
Research Site
Taichung, 40705
Taiwan
Recruiting
Research Site
Tainan, 704
Taiwan
Recruiting
Research Site
Taipei, 100
Taiwan
Withdrawn
Research Site
Taipei, 11217
Taiwan
Recruiting
Research Site
Pathumwan, 10330
Thailand
Not yet recruiting
Research Site
Songkhla, 90110
Thailand
Not yet recruiting
Research Site
Adana, 01120
Turkey
Not yet recruiting
Research Site
Istanbul, 34098
Turkey
Not yet recruiting
Research Site
Chernivtsі, 58013
Ukraine
Not yet recruiting
Research Site
Dnipro, 49102
Ukraine
Recruiting
Research Site
Ivano-Frankivsk, 76018
Ukraine
Not yet recruiting
Research Site
Kharkiv Region, 61070
Ukraine
Recruiting
Research Site
Kirovohrad, 25006
Ukraine
Recruiting
Research Site
Kryvyi Rih, 50048
Ukraine
Recruiting
Research Site
Kyiv, 03022
Ukraine
Recruiting
Research Site
Kyiv, 03115
Ukraine
Not yet recruiting
Research Site
Kyiv, 8112
Ukraine
Recruiting
Research Site
Odesa, 65055
Ukraine
Not yet recruiting
Research Site
Uzhhorod, 88014
Ukraine
Recruiting
Research Site
Vinnytsia, 21029
Ukraine
Recruiting
Research Site
Glasgow, G12 0YN
United Kingdom
Recruiting
Research Site
London, EC1A 7BE
United Kingdom
Recruiting
Research Site
Manchester, M20 4BX
United Kingdom
Recruiting
Research Site
Taunton, TA1 5DA
United Kingdom
Withdrawn
Research Site
Hanoi, 100000
Vietnam
Not yet recruiting
Research Site
Hanoi, 100000
Vietnam
Withdrawn
Research Site
Ho Chi Minh, 700000
Vietnam
Not yet recruiting