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

Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-08-31
Last Posted Date
2023-02-10
Lead Sponsor
Simon C Pacey, MD
Target Recruit Count
18
Registration Number
NCT03653052
Locations
🇬🇧

Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab

First Posted Date
2018-08-20
Last Posted Date
2023-12-05
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
30
Registration Number
NCT03638141
Locations
🇺🇸

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

Radiotherapy With Durvalumab Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma

First Posted Date
2018-08-17
Last Posted Date
2024-12-19
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
21
Registration Number
NCT03635164
Locations
🇺🇸

University of Colorado Hospital, Aurora, Colorado, United States

🇺🇸

Memorial Hospital Central, Colorado Springs, Colorado, United States

🇺🇸

Poudre Valley Hospital, Fort Collins, Colorado, United States

Feasibility & Efficacy of Durvalumab+Tremelimumab+RT and Durvalumab+RT in Non-resect. Locally Advanced HPVnegativ HNSCC

First Posted Date
2018-08-10
Last Posted Date
2023-08-31
Lead Sponsor
Ulrich Keilholz
Target Recruit Count
18
Registration Number
NCT03624231
Locations
🇩🇪

Charité Comprehensive Cancer Center, Berlin, Germany

🇩🇪

Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany

🇩🇪

Vivantes Klinikum Neukölln, Berlin, Germany

1st Line Durvalumab in PS 2 NSCLC Patients

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-08-08
Last Posted Date
2024-01-17
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
48
Registration Number
NCT03620669
Locations
🇨🇭

Spital STS AG, Thun, Switzerland

🇨🇭

Kantonsspital Graubuenden, Chur, Switzerland

🇨🇭

Hopital Fribourgeois HFR, Fribourg, Switzerland

and more 8 locations

MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.

First Posted Date
2018-08-02
Last Posted Date
2023-10-03
Lead Sponsor
MedImmune LLC
Target Recruit Count
213
Registration Number
NCT03611556
Locations
🇪🇸

Research Site, Pamplona, Spain

A Trial of Radiotherapy and Durvalumab in DLBCL and FL

First Posted Date
2018-08-01
Last Posted Date
2024-04-12
Lead Sponsor
Austin Health
Target Recruit Count
34
Registration Number
NCT03610061
Locations
🇦🇺

Princess Alexandra Hospital, Brisbane, Queensland, Australia

🇦🇺

Monash Health, Clayton, Victoria, Australia

🇦🇺

Austin Health, Heidelberg, Victoria, Australia

Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

First Posted Date
2018-07-31
Last Posted Date
2024-12-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
70
Registration Number
NCT03606967
Locations
🇺🇸

Moffitt Cancer Center at Wesley Chapel, Wesley Chapel, Florida, United States

🇺🇸

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

🇺🇸

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 27 locations

Window of Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple Negative or Low ER+ Breast Cancer

First Posted Date
2018-07-20
Last Posted Date
2021-06-22
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
54
Registration Number
NCT03594396
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

© Copyright 2024. All Rights Reserved by MedPath