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Durvalumab Long-Term Safety and Efficacy Study

NCT ID: NCT04078152

Last Updated: 2024-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Solid Tumor

Keywords

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non-small cell lung cancer (NSCLC) urothelial cancer durvalumab long-term safety, efficacy overall survival immunotherapy checkpoint inhibitor PD-L1 retreatment Gastric adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

All involved know the identity of the intervention assignment.

Study Groups

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Treatment

Durvalumab Monotherapy

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

IV infusion q4w with 1500mg durvalumab until progressive disease

Off Treatment

Follow up Only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Durvalumab

IV infusion q4w with 1500mg durvalumab until progressive disease

Intervention Type DRUG

Other Intervention Names

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MEDI4736

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iqvia Pty Ltd

INDUSTRY

Sponsor Role collaborator

Parexel

INDUSTRY

Sponsor Role collaborator

Medidata Solutions

INDUSTRY

Sponsor Role collaborator

CISCRP

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jared Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Research Site

Fullerton, California, United States

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Washington D.C., District of Columbia, United States

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Augusta, Georgia, United States

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Baltimore, Maryland, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Mineola, New York, United States

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Chapel Hill, North Carolina, United States

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Huntersville, North Carolina, United States

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Greenville, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Rosario, , Argentina

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Box Hill, , Australia

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Melbourne, , Australia

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Brussels, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Florianópolis, , Brazil

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Ijuí, , Brazil

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Porto Alegre, , Brazil

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São José do Rio Preto, , Brazil

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Sofia, , Bulgaria

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Calgary, Alberta, Canada

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Toronto, CA, Canada

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Greater Sudbury, Ontario, Canada

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Newmarket, Ontario, Canada

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Santiago, , Chile

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Olomouc, , Czechia

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Brest, , France

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Lille, , France

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Lyon, , France

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Dresden, , Germany

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Hanover, , Germany

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Holargos, Athens, , Greece

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Budapest, , Hungary

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Miskolc, , Hungary

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Chennai, , India

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Haifa, , Israel

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Bunkyō City, , Japan

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Fukushima, , Japan

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Isehara-shi, , Japan

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Izumi-shi, , Japan

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Kishiwada-shi, , Japan

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Kōtoku, , Japan

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Nagaoka-shi, , Japan

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Nagoya, , Japan

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Natori-shi, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Saga, , Japan

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Suita-shi, , Japan

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Sunto-gun, , Japan

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Tokushima, , Japan

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Yokohama, , Japan

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Kuching, , Malaysia

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Lodz, , Poland

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Lodz, , Poland

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Olsztyn, , Poland

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Craiova, , Romania

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Suceava, , Romania

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Arkhangelsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Omsk, , Russia

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pos.Pesochnyi, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Kamenitz, , Serbia

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Daegu, , South Korea

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Gwangju, , South Korea

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Gyeongsangnam-do, , South Korea

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Seogu, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Girona, , Spain

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Jaén, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Marbella, , Spain

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Málaga, , Spain

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Valencia, , Spain

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Bellinzona, , Switzerland

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Lausanne, , Switzerland

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New Taipei City, , Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Songkhla, , Thailand

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Adana, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Chernivtsі, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kirovohrad, , Ukraine

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Kryvyi Rih, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Sumy, , Ukraine

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Uzhhorod, , Ukraine

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Vinnytsia, , Ukraine

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Hanoi, , Vietnam

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Countries

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China Italy Mexico United States Argentina Australia Belgium Brazil Bulgaria Canada Chile Czechia France Germany Greece Hungary India Israel Japan Malaysia Netherlands Poland Romania Russia Serbia South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom Vietnam

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D910FC00001&amp;attachmentIdentifier=b7d44aa5-4d78-4092-8fc0-b76fe76a81c0&amp;fileName=D910FC00001-CSP_v4_Redacted.pdf&amp;versionIdentifier=

Redacted CSP

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D910FC00001&amp;attachmentIdentifier=0c28a623-3d31-469f-9b63-0200f0df8a66&amp;fileName=D910FC00001-SAP_v2_Redacted.pdf&amp;versionIdentifier=

Redacted SAP

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D910FC00001&amp;attachmentIdentifier=89671fcd-e198-4fb4-9f13-613cd6907b63&amp;fileName=D910FC00001-CSR_synopsis_Redacted.pdf&amp;versionIdentifier=

Redacted CSR Synopsis

Other Identifiers

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2019-001402-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D910FC00001

Identifier Type: -

Identifier Source: org_study_id