Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1428935-60-7
Unique Ingredient Identifier
28X28X9OKV
Background

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.

Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Indication

Durvalumab is indicated for the treatment of adults with the following conditions:

Associated Conditions
Extensive-stage Small Cell Lung Cancer (SCLC), Locally Advanced Biliary Tract Cancer, Metastatic Biliary Tract Cancer, Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC), Unresectable Stage III Non-small Cell Lung Cancer, Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
Associated Therapies
First Line Chemotherapy

Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

First Posted Date
2020-03-10
Last Posted Date
2024-02-20
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
5
Registration Number
NCT04301778
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

AZD6738 Plus Durvalumab in Biliary Tract Cancer

First Posted Date
2020-03-06
Last Posted Date
2024-04-19
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
26
Registration Number
NCT04298008
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

DDR-Umbrella Study of DDR Targeting Agents in Advanced Biliary Tract Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-03-06
Last Posted Date
2024-04-19
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
74
Registration Number
NCT04298021
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-03-04
Last Posted Date
2024-08-22
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
30
Registration Number
NCT04294498
Locations
🇨🇳

National Taiwan University Hospital, Taipei City, Taiwan

Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment

First Posted Date
2020-02-27
Last Posted Date
2024-11-06
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
18
Registration Number
NCT04287894
Locations
🇳🇱

Antoni van Leeuwenhoek - Netherlands Cancer Institute, Amsterdam, Noord-Holland, Netherlands

Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.

Completed
Conditions
Interventions
First Posted Date
2020-02-26
Last Posted Date
2022-06-07
Lead Sponsor
Fundación GECP
Target Recruit Count
245
Registration Number
NCT04285866
Locations
🇪🇸

Hospital General de Alicante, Alicante, Spain

🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain

🇪🇸

Hospital Universitario Reina Sofía, Córdoba, Spain

and more 36 locations

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

First Posted Date
2020-02-13
Last Posted Date
2024-11-20
Lead Sponsor
AstraZeneca
Target Recruit Count
805
Registration Number
NCT04269200
Locations
🇪🇸

Research Site, Mallorca, Spain

Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer

First Posted Date
2020-02-06
Last Posted Date
2023-05-01
Lead Sponsor
GWT-TUD GmbH
Target Recruit Count
75
Registration Number
NCT04257448
Locations
🇩🇪

Universitätsklinikum Essen, Essen, Germany

🇩🇪

Universitätsmedizin Göttingen, Göttingen, Germany

🇩🇪

Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

and more 6 locations

Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2020-01-30
Last Posted Date
2024-04-09
Lead Sponsor
AstraZeneca
Target Recruit Count
102
Registration Number
NCT04249362
Locations
🇪🇸

Research Site, Sabadell(Barcelona), Spain

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