Durvalumab Long-Term Safety and Efficacy Study

INTRODUCTION

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

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.

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 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

Solid Tumor

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

Name: Jared Weiss, MD

Role: Principal Investigator

Affiliation: University of North Carolina, Chapel Hill

Name: Jared Weiss, MD

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

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	Status: Recruiting	Contact: N/A
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	Status: Recruiting	Contact: N/A
Facility: Research Site Dallas, Texas 75251 United States	Status: Recruiting	Contact: N/A
Facility: Research Site Box Hill, 3128 Australia	Status: Recruiting	Contact: N/A
Facility: Research Site Melbourne, 3000 Australia	Status: Recruiting	Contact: N/A
Facility: Research Site Ijuí, 98700-000 Brazil	Status: Recruiting	Contact: N/A
Facility: Research Site Sao Jose Rio Preto, 15090-000 Brazil	Status: Recruiting	Contact: N/A
Facility: Research Site Calgary, Alberta T2N 4N2 Canada	Status: Recruiting	Contact: N/A
Facility: Research Site Toronto, CA M5G 2M9 Canada	Status: Recruiting	Contact: N/A
Facility: Research Site Newmarket, Ontario L3Y 2P9 Canada	Status: Recruiting	Contact: N/A
Facility: Research Site Sudbury, Ontario P3E 5J1 Canada	Status: Recruiting	Contact: N/A
Facility: Research Site Hannover, 30625 Germany	Status: Recruiting	Contact: N/A
Facility: Research Site Budapest, 1121 Hungary	Status: Recruiting	Contact: N/A
Facility: Research Site Miskolc, 3529 Hungary	Status: Recruiting	Contact: N/A
Facility: Research Site Haifa, 91096 Israel	Status: Recruiting	Contact: N/A
Facility: Research Site Fukushima-shi, 960-1295 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Hirakata-shi, 573-1191 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Isehara-shi, 259-1193 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Izumi-shi, 594-0073 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Koto-ku, 135-8550 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Nagaoka-shi, 940-2085 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Natori-shi, 981-1293 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Okayama-shi, 700-8558 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Osaka-shi, 541-8567 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Saga-shi, 840-8571 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Sunto-gun, 411-8777 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Tokushima-shi, 770-8503 Japan	Status: Recruiting	Contact: N/A
Facility: Research Site Yokohama-shi, 241-8515 Japan	Status: Recruiting	Contact: N/A
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	Status: Recruiting	Contact: N/A
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	Status: Recruiting	Contact: N/A
Facility: Research Site Amsterdam, 1066 CX Netherlands	Status: Recruiting	Contact: N/A
Facility: Research Site Arnhem, 6815 AD Netherlands	Status: Recruiting	Contact: N/A
Facility: Research Site Bielsko-Biała, 43-300 Poland	Status: Recruiting	Contact: N/A
Facility: Research Site Łódź, 90-302 Poland	Status: Recruiting	Contact: N/A
Facility: Research Site Arkhangelsk, 163045 Russian Federation	Status: Recruiting	Contact: N/A
Facility: Research Site Moscow, 111123 Russian Federation	Status: Recruiting	Contact: N/A
Facility: Research Site Obninsk, 249036 Russian Federation	Status: Recruiting	Contact: N/A
Facility: Research Site Omsk, 644013 Russian Federation	Status: Recruiting	Contact: N/A
Facility: Research Site pos.Pesochnyi, 197758 Russian Federation	Status: Recruiting	Contact: N/A
Facility: Research Site Saint-Petersburg, 197022 Russian Federation	Status: Recruiting	Contact: N/A
Facility: Research Site Saint-Petersburg, 197758 Russian Federation	Status: Recruiting	Contact: N/A
Facility: Research Site Sremska Kamenica, 21204 Serbia	Status: Recruiting	Contact: N/A
Facility: Research Site Badalona, 08916 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Barcelona, 08028 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Barcelona, 08035 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Barcelona, 08041 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Girona, 17007 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Madrid, 28007 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Madrid, 28034 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Madrid, 28041 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Madrid, 28046 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Marbella, 29600 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Málaga, 29010 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Sevilla, 41013 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Valencia, 46015 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Valencia, 46026 Spain	Status: Recruiting	Contact: N/A
Facility: Research Site Lausanne, 1011 Switzerland	Status: Recruiting	Contact: N/A
Facility: Research Site New Taipei, 23561 Taiwan	Status: Recruiting	Contact: N/A
Facility: Research Site Taichung, 40447 Taiwan	Status: Recruiting	Contact: N/A
Facility: Research Site Taichung, 40705 Taiwan	Status: Recruiting	Contact: N/A
Facility: Research Site Tainan, 704 Taiwan	Status: Recruiting	Contact: N/A
Facility: Research Site Taipei, 11217 Taiwan	Status: Recruiting	Contact: N/A
Facility: Research Site Bangkok, 10330 Thailand	Status: Recruiting	Contact: N/A
Facility: Research Site Songkhla, 90110 Thailand	Status: Recruiting	Contact: N/A
Facility: Research Site Chernivtsі, 58013 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Dnipro, 49102 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Ivano-Frankivsk, 76018 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Kharkiv Region, 61070 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Kirovohrad, 25006 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Kryvyi Rih, 50048 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Kyiv, 03022 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Kyiv, 03115 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Kyiv, 8112 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Uzhhorod, 88014 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Vinnytsia, 21029 Ukraine	Status: Recruiting	Contact: N/A
Facility: Research Site Glasgow, G12 0YN United Kingdom	Status: Recruiting	Contact: N/A
Facility: Research Site London, EC1A 7BE United Kingdom	Status: Recruiting	Contact: N/A
Facility: Research Site Manchester, M20 4BX United Kingdom	Status: Recruiting	Contact: N/A

Brief Title: Durvalumab Long-Term Safety and Efficacy Study

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

BRIEF SUMMARY

DETAILED DESCRIPTION

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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