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 "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas

First Posted Date
2018-04-06
Last Posted Date
2023-10-12
Lead Sponsor
Baptist Health South Florida
Target Recruit Count
9
Registration Number
NCT03490760
Locations
🇺🇸

Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States

Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

First Posted Date
2018-03-29
Last Posted Date
2022-09-08
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
70
Registration Number
NCT03482102
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Durvalumab (MEDI4736) and TREmelimumab in NEOadjuvant Bladder Cancer Patients (DUTRENEO)

First Posted Date
2018-03-21
Last Posted Date
2023-04-13
Lead Sponsor
Fundacion CRIS de Investigación para Vencer el Cáncer
Target Recruit Count
101
Registration Number
NCT03472274
Locations
🇪🇸

Hospital Clinic, Barcelona, Spain

🇪🇸

ICO L'Hospitalet, L'Hospitalet De Llobregat, Spain

🇪🇸

ICO Badalona, Badalona, Spain

and more 8 locations

A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-03-09
Last Posted Date
2024-11-21
Lead Sponsor
AstraZeneca
Target Recruit Count
154
Registration Number
NCT03459846
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2018-02-27
Last Posted Date
2023-11-14
Lead Sponsor
Vastra Gotaland Region
Target Recruit Count
106
Registration Number
NCT03446547
Locations
🇫🇮

Helsinki, Helsinki, Finland

🇸🇪

Dept of Oncology, Stockholm, Sweden

🇫🇮

Turku, Turku, Finland

and more 4 locations

Durvalumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-02-15
Last Posted Date
2024-10-14
Lead Sponsor
Asan Medical Center
Target Recruit Count
33
Registration Number
NCT03435107
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer

First Posted Date
2018-02-13
Last Posted Date
2020-08-05
Lead Sponsor
Amy Tiersten
Target Recruit Count
9
Registration Number
NCT03430518
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer

First Posted Date
2018-02-09
Last Posted Date
2023-06-15
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
29
Registration Number
NCT03428126
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer

First Posted Date
2018-02-05
Last Posted Date
2019-04-16
Lead Sponsor
Iovance Biotherapeutics, Inc.
Registration Number
NCT03419559
Locations
🇺🇸

UPMC Cancer Center, Pittsburgh, Pennsylvania, United States

🇺🇸

University of Washington Medical Center, Seattle, Washington, United States

🇺🇸

University of California San Diego, Moores Cancer Center, La Jolla, California, United States

and more 5 locations
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