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

Chemo-immunotherapy, Hypo-fractionated RT and Maintenance Immunotherapy for Stage III NSCLC.

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2021-11-22
Last Posted Date
2023-09-28
Lead Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Target Recruit Count
45
Registration Number
NCT05128630
Locations
🇮🇹

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC

First Posted Date
2021-10-25
Last Posted Date
2024-01-12
Lead Sponsor
You Lu
Target Recruit Count
30
Registration Number
NCT05092412
Locations
🇨🇳

Chongqing University Cancer Hospital, Chongqing, Chongqing, China

🇨🇳

Henan Provincial People's Hospital, Zhengzhou, He Nan, China

🇨🇳

West China Hospital Sichuan University, Chengdu, Si Chuan, China

Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)

First Posted Date
2021-10-05
Last Posted Date
2024-05-14
Lead Sponsor
University of Chicago
Target Recruit Count
49
Registration Number
NCT05068232
Locations
🇺🇸

University of Chicago Medicine, Chicago, Illinois, United States

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-09-29
Last Posted Date
2024-11-15
Lead Sponsor
AstraZeneca
Target Recruit Count
194
Registration Number
NCT05061134
Locations
🇬🇧

Research Site, Northwood, United Kingdom

Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-09-13
Last Posted Date
2024-12-16
Lead Sponsor
AstraZeneca
Target Recruit Count
147
Registration Number
NCT05043090
Locations
🇬🇧

Research Site, London, United Kingdom

Durvalumab With Chemotherapy Followed by Sequential Radiotherapy for Limited Stage Small Cell Lung Cancer

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2021-09-05
Last Posted Date
2021-09-05
Lead Sponsor
Beijing Haidian Hospital
Target Recruit Count
20
Registration Number
NCT05034133
Locations
🇨🇳

Beijing Haidian Hospital, Beijing, China

Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant

First Posted Date
2021-08-30
Last Posted Date
2024-11-22
Lead Sponsor
Davendra Sohal
Target Recruit Count
30
Registration Number
NCT05027425
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

University of Cincinnati, Cincinnati, Ohio, United States

🇺🇸

Simmons Comprehensive Cancer Center UT Southwestern Medical Center, Dallas, Texas, United States

Concomitant Radiotherapy, Tremelimumab & Durvalumab for Advanced NSCLC Patients Progressing on First-line Immunotherapy

First Posted Date
2021-08-11
Last Posted Date
2024-12-05
Lead Sponsor
Sheba Medical Center
Target Recruit Count
29
Registration Number
NCT05000710
Locations
🇮🇱

Sheba Medical Centre, Ramat Gan, Israel

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