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
A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
- Conditions
- Merkel Cell CarcinomaSarcomaCutaneous T-Cell LymphomaMelanomaRenal CancerSolid TumorBladder CancerProstate CancerTesticular CancerHead and Neck Squamous Cell Carcinoma
- Interventions
- First Posted Date
- 2015-12-31
- Last Posted Date
- 2022-12-02
- Lead Sponsor
- Ludwig Institute for Cancer Research
- Target Recruit Count
- 58
- Registration Number
- NCT02643303
- Locations
- 🇺🇸
Research Facility, Charlottesville, Virginia, United States
Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers
- Conditions
- MetastaticMelanomaNon Small Cell Lung Cancer (NSCLC)Pancreatic CancerBreast Cancer
- Interventions
- First Posted Date
- 2015-12-24
- Last Posted Date
- 2025-03-25
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Target Recruit Count
- 53
- Registration Number
- NCT02639026
- Locations
- 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
A Study of Durvalumab (MEDI4736) in Esophageal Cancer
- First Posted Date
- 2015-12-24
- Last Posted Date
- 2023-09-25
- Lead Sponsor
- Shadia Jalal, MD
- Target Recruit Count
- 39
- Registration Number
- NCT02639065
- Locations
- 🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸Unversity of Iowa Hospital and Clinics, Iowa City, Iowa, United States
🇺🇸University of Michigan Health System, Ann Arbor, Michigan, United States
Study of Safety and Efficacy of Durvalumab in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer Patients
- First Posted Date
- 2015-12-11
- Last Posted Date
- 2020-07-07
- Target Recruit Count
- 22
- Registration Number
- NCT02628132
- Locations
- 🇸🇦
King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2015-11-30
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- Celgene
- Target Recruit Count
- 114
- Registration Number
- NCT02616640
- Locations
- 🇺🇸
Local Institution - 108, Boston, Massachusetts, United States
🇺🇸Local Institution - 115, Boston, Massachusetts, United States
🇪🇸Local Institution - 504, Madrid, Spain
Safety, Tolerability and Pharmacokinetics of AZD1775 (Adavosertib) Plus MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumours
- Conditions
- Advanced Solid Tumours
- Interventions
- First Posted Date
- 2015-11-30
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 56
- Registration Number
- NCT02617277
- Locations
- 🇺🇸
Research Site, Nashville, Tennessee, United States
MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma
- Conditions
- Mesothelioma
- Interventions
- First Posted Date
- 2015-10-30
- Last Posted Date
- 2022-09-29
- Lead Sponsor
- Baylor College of Medicine
- Target Recruit Count
- 24
- Registration Number
- NCT02592551
- Locations
- 🇺🇸
Baylor St Lukes, Houston, Texas, United States
A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours
- Conditions
- MelanomaLung CancerBreast CancerPancreatic AdenocarcinomaBiliary Tract CancerHead and Neck CarcinomaGastroesophageal CancerColorectal Cancer
- Interventions
- First Posted Date
- 2015-10-27
- Last Posted Date
- 2019-11-18
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 58
- Registration Number
- NCT02586987
- Locations
- 🇺🇸
Research Site, Pittsburgh, Pennsylvania, United States
A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies
- Conditions
- Gastric CancerGastroesophageal Junction AdenocarcinomaNon-Small Cell Lung CancerHepatocellular Carcinoma
- Interventions
- First Posted Date
- 2015-10-09
- Last Posted Date
- 2021-01-20
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 85
- Registration Number
- NCT02572687
- Locations
- 🇺🇸
UCLA Medical Center, Santa Monica, California, United States
🇺🇸Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸Washington University Medical Center, Saint Louis, Missouri, United States
Brain Irradiation and Tremelimumab in Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Radiation: Brain radiotherapy or Stereotactic RadiosurgeryDrug: HER2 directed therapy
- First Posted Date
- 2015-09-30
- Last Posted Date
- 2022-08-03
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 28
- Registration Number
- NCT02563925
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Drug Development Updates
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