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
CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC)
- Conditions
- Interventions
- First Posted Date
- 2019-10-04
- Last Posted Date
- 2024-07-29
- Lead Sponsor
- University of Birmingham
- Target Recruit Count
- 785
- Registration Number
- NCT04116047
- Locations
- 🇬🇧
Colchester General Hospital, Colchester, Essex, United Kingdom
🇬🇧James Cook University Hospital, Middlesbrough, North Yorkshire, United Kingdom
🇬🇧Aberdeen Royal Infirmary, Aberdeen, United Kingdom
Diadem to Investigate the Activity and Safety of Durvalumab
- First Posted Date
- 2019-10-03
- Last Posted Date
- 2023-03-15
- Target Recruit Count
- 57
- Registration Number
- NCT04115111
- Locations
- 🇮🇹
San Gerardo Hospital, Monza, Italy
Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-09-30
- Last Posted Date
- 2023-10-17
- Lead Sponsor
- Chandrikha Chandrasekharan
- Target Recruit Count
- 18
- Registration Number
- NCT04108481
- Locations
- 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Immunotherapy in Patient with Poor General Condition
- Conditions
- Interventions
- First Posted Date
- 2019-09-27
- Last Posted Date
- 2024-10-15
- Target Recruit Count
- 50
- Registration Number
- NCT04108026
- Locations
- 🇫🇷
Besançon - CHU, Besançon, France
🇫🇷Caen - CHU Côte de Nacre, Caen, France
🇫🇷Paris - APHP Bichat, Paris, France
Microbiome Immunotherapy Toxicity and Response Evaluation
- First Posted Date
- 2019-09-27
- Last Posted Date
- 2023-02-16
- Lead Sponsor
- CCTU- Cancer Theme
- Target Recruit Count
- 1800
- Registration Number
- NCT04107168
- Locations
- 🇬🇧
University Hospitals Dorest NHS Foundation Trust, Bournemouth, United Kingdom
🇬🇧Royal United Hospitals Bath NHS Foundation Trust, Bath, United Kingdom
🇬🇧Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
- First Posted Date
- 2019-09-26
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- University College, London
- Target Recruit Count
- 64
- Registration Number
- NCT04106115
- Locations
- 🇬🇧
The Royal Marsden NHS Foundation Trust, London, United Kingdom
🇬🇧University College London Hospital NHS Foundation Trust, London, United Kingdom
🇬🇧The Christie NHS Foundation Trust, Manchester, United Kingdom
Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-09-17
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 660
- Registration Number
- NCT04092283
- Locations
- 🇺🇸
Springfield Memorial Hospital, Springfield, Illinois, United States
🇺🇸Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
🇺🇸Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-09-13
- Last Posted Date
- 2024-04-16
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 59
- Registration Number
- NCT04089553
- Locations
- 🇺🇸
Research Site, Nashville, Tennessee, United States
Capecitabine Plus Concomitant Radiation Therapy Followed by Durvalumab as Preoperative Treatment in Rectal Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-09-10
- Last Posted Date
- 2023-05-31
- Lead Sponsor
- AUSL Romagna Rimini
- Target Recruit Count
- 100
- Registration Number
- NCT04083365
- Locations
- 🇮🇹
Ospedale Degli Infermi Uo Oncologia, Faenza, Italy
Durvalumab Long-Term Safety and Efficacy Study
- First Posted Date
- 2019-09-04
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 163
- Registration Number
- NCT04078152
- Locations
- 🇻🇳
Research Site, Hanoi, Vietnam
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.