Durvalumab
- Generic Name
- Durvalumab
- Brand Names
- Imfinzi
- Drug Type
- Biotech
- 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
BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: BC3402 injection
- First Posted Date
- 2023-11-01
- Last Posted Date
- 2023-11-01
- Lead Sponsor
- Biocity Biopharmaceutics Co., Ltd.
- Target Recruit Count
- 83
- Registration Number
- NCT06111326
- Locations
- 🇨🇳
Zhongshan Hospital, Fudan University, Shanghai, China
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2023-11-01
- Last Posted Date
- 2025-03-10
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1728
- Registration Number
- NCT06112379
- Locations
- 🇻🇳
Research Site, Vinh, Vietnam
A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)
- Conditions
- Hepatocellular Carcinoma
- Interventions
- First Posted Date
- 2023-10-31
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 660
- Registration Number
- NCT06109272
- Locations
- 🇫🇷
Hopital Beaujon /ID# 256551, Clichy, Ile-de-France, France
🇫🇷CHU Grenoble - Hopital Michallon /ID# 256627, La Tronche, Isere, France
🇺🇸City of Hope /ID# 261468, Duarte, California, United States
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2023-10-27
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 625
- Registration Number
- NCT06103864
- Locations
- 🇻🇳
Research Site, Vinh, Vietnam
NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- First Posted Date
- 2023-10-23
- Last Posted Date
- 2024-12-03
- Lead Sponsor
- Australasian Gastro-Intestinal Trials Group
- Target Recruit Count
- 20
- Registration Number
- NCT06094140
- Locations
- 🇦🇺
GenesisCare North Shore, Sydney, New South Wales, Australia
🇦🇺Wollongong Hospital, Wollongong, New South Wales, Australia
🇦🇺Warringal Private Hospital, Melbourne, Victoria, Australia
Ascorbate with Durvalumab in Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2023-10-16
- Last Posted Date
- 2024-11-04
- Lead Sponsor
- Muhammad Furqan
- Target Recruit Count
- 36
- Registration Number
- NCT06083454
- Locations
- 🇺🇸
University of Iowa, Iowa City, Iowa, United States
DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
- Conditions
- Small Cell Lung Carcinoma (SCLC)
- Interventions
- First Posted Date
- 2023-10-11
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 60
- Registration Number
- NCT06077500
- Locations
- 🇺🇸
Orlando Health Cancer Institute, Orlando, Florida, United States
🇺🇸Emory University, Atlanta, Georgia, United States
🇧🇪Brussels - UNIV Saint-Luc, Bruxelles, Belgium
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma
- Conditions
- Gastrointestinal Neuroendocrine Carcinoma
- Interventions
- First Posted Date
- 2023-10-06
- Last Posted Date
- 2023-10-06
- Lead Sponsor
- Peking Union Medical College Hospital
- Target Recruit Count
- 22
- Registration Number
- NCT06070740
- Locations
- 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China
Durvalumab and Oleclumab in Resectable PDAC
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- First Posted Date
- 2023-09-29
- Last Posted Date
- 2024-01-08
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 22
- Registration Number
- NCT06060405
- Locations
- 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Radioembolization with Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
- Conditions
- Locally Advanced Intrahepatic CholangiocarcinomaOligometastatic Intrahepatic CholangiocarcinomaStage III Intrahepatic Cholangiocarcinoma AJCC V8Stage IV Intrahepatic Cholangiocarcinoma AJCC V8Unresectable Intrahepatic Cholangiocarcinoma
- Interventions
- Procedure: AngiographyProcedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyProcedure: Yttrium-90 Microsphere Radioembolization
- First Posted Date
- 2023-09-28
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 18
- Registration Number
- NCT06058663
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
Drug Development Updates
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