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
TRIO Bladder: A Study of Durvalumab Plus Tremelimumab Followed by Concurrent Durvalumab Plus Bladder Radiation in Muscle-Invasive Bladder Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-08-29
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Daniel George, MD
- Registration Number
- NCT04073160
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC
- Conditions
- Interventions
- First Posted Date
- 2019-08-28
- Last Posted Date
- 2023-11-15
- Lead Sponsor
- MedImmune LLC
- Target Recruit Count
- 61
- Registration Number
- NCT04068610
- Locations
- 🇪🇸
Research Site, Madrid, Spain
ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss
- Conditions
- Interventions
- First Posted Date
- 2019-08-22
- Last Posted Date
- 2024-07-11
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Target Recruit Count
- 174
- Registration Number
- NCT04065269
- Locations
- 🇬🇧
Royal United Hospital, Bath, United Kingdom
🇬🇧Western General Hospital, Edinburgh, United Kingdom
🇬🇧The Beatson, Glasgow, United Kingdom
CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-08-20
- Last Posted Date
- 2024-02-05
- Lead Sponsor
- Alliance Foundation Trials, LLC.
- Target Recruit Count
- 38
- Registration Number
- NCT04062708
- Locations
- 🇺🇸
Baptist Cancer Center, Memphis, Tennessee, United States
🇺🇸NorthWestern University, Chicago, Illinois, United States
🇺🇸University of Chicago Medical Center, Chicago, Illinois, United States
Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma
- First Posted Date
- 2019-08-13
- Last Posted Date
- 2019-08-13
- Lead Sponsor
- Tiago Biachi
- Target Recruit Count
- 22
- Registration Number
- NCT04054518
- Locations
- 🇧🇷
Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil
Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.
- Conditions
- Interventions
- First Posted Date
- 2019-08-12
- Last Posted Date
- 2024-02-05
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 172
- Registration Number
- NCT04053322
- Locations
- 🇫🇷
Centre Henri-Becquerel, Rouen, France
🇫🇷Institut de Cancerologie de Montpellier, Montpellier, France
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
- Conditions
- Interventions
- First Posted Date
- 2019-07-19
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 925
- Registration Number
- NCT04026412
- Locations
- 🇺🇸
Local Institution - 0071, Burlington, Vermont, United States
🇺🇸Local Institution - 0124, Cleveland, Ohio, United States
🇺🇸Local Institution - 0053, Cincinnati, Ohio, United States
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Conditions
- Refractory Ovarian CarcinomaPlatinum-Resistant Ovarian CarcinomaRecurrent Fallopian Tube CarcinomaRefractory Fallopian Tube CarcinomaPlatinum-Resistant Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaRefractory Primary Peritoneal Carcinoma
- Interventions
- First Posted Date
- 2019-07-15
- Last Posted Date
- 2024-10-28
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 12
- Registration Number
- NCT04019288
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients
- Conditions
- Interventions
- Locations
- 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸Mount Sinai School of Medicine, The Tisch Cancer Institute, New York, New York, United States
🇺🇸Mount Sinai School of Medicine, New York, New York, United States
Determining Whether Durvalumab in Combination With Radiation Therapy Can Prevent the Progression of Non-Small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-06-27
- Last Posted Date
- 2024-10-17
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 61
- Registration Number
- NCT03999710
- Locations
- 🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Nassau, Uniondale, New York, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.