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

Radiation Therapy in Combination With Durvalumab for People With Pancreatic Cancer

First Posted Date
2017-08-10
Last Posted Date
2024-10-07
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
18
Registration Number
NCT03245541
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States

🇺🇸

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States

and more 4 locations

Durvalumab in DLBCL After Autologous Transplant

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2017-08-07
Last Posted Date
2018-04-09
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Registration Number
NCT03241017

A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors

First Posted Date
2017-08-03
Last Posted Date
2024-05-17
Lead Sponsor
Syndax Pharmaceuticals
Target Recruit Count
45
Registration Number
NCT03238027
Locations
🇺🇸

Honor Health, Scottsdale, Arizona, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

and more 2 locations

Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

First Posted Date
2017-08-02
Last Posted Date
2024-07-12
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
9
Registration Number
NCT03237377
Locations
🇺🇸

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma

First Posted Date
2017-08-01
Last Posted Date
2018-03-15
Lead Sponsor
University of Michigan Rogel Cancer Center
Registration Number
NCT03235869
Locations
🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer

First Posted Date
2017-07-11
Last Posted Date
2024-03-28
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
54
Registration Number
NCT03212469
Locations
🇫🇷

Gustave Roussy, Villejuif, Val De Marne, France

Study Of Durvalumab and Lenalidomide In R/R EBV Associated DLBCL Subtypes, Primary CNS And Testicular DLBCL

First Posted Date
2017-07-11
Last Posted Date
2018-09-13
Lead Sponsor
Singapore General Hospital
Registration Number
NCT03212807
Locations
🇸🇬

National University Hospital, Singapore, Singapore

🇸🇬

Raffles Hospital, Singapore, Singapore

🇸🇬

Singapore General Hospital, Singapore, Singapore

and more 1 locations

A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer

First Posted Date
2017-07-02
Last Posted Date
2023-10-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
34
Registration Number
NCT03206073
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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