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 Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Radiation: Hypofractionated stereotactic radiation therapy
- First Posted Date
- 2016-08-15
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Institut Claudius Regaud
- Target Recruit Count
- 108
- Registration Number
- NCT02866747
- Locations
- 🇫🇷
Hopital Avicenne, Bobigny, France
🇫🇷Institut de Cancerologie de L'Ouest, Angers, France
🇫🇷Centre Georges Francois Leclerc, Dijon, France
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2016-07-11
- Last Posted Date
- 2023-11-14
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 22
- Registration Number
- NCT02826434
- Locations
- 🇺🇸
New York University School of Medicine, New York, New York, United States
🇺🇸Massachusetts general Hospital, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer
- Conditions
- Stage II Oropharyngeal Squamous Cell CarcinomaStage III Oral Cavity Squamous Cell CarcinomaStage IVC Oropharyngeal Squamous Cell CarcinomaStage I Oropharyngeal Squamous Cell CarcinomaHuman Papillomavirus InfectionStage IVA Oral Cavity Squamous Cell CarcinomaStage IVB Oropharyngeal Squamous Cell CarcinomaStage I Oral Cavity Squamous Cell CarcinomaStage II Oral Cavity Squamous Cell CarcinomaStage III Oropharyngeal Squamous Cell Carcinoma
- Interventions
- Other: Laboratory Biomarker AnalysisProcedure: Therapeutic Conventional Surgery
- First Posted Date
- 2016-07-11
- Last Posted Date
- 2025-03-17
- Lead Sponsor
- Wake Forest University Health Sciences
- Target Recruit Count
- 17
- Registration Number
- NCT02827838
- Locations
- 🇺🇸
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States
A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)
- Conditions
- Bile Duct CancerBiliary Tract NeoplasmsHepatocellular CarcinomaCholangiocarcinomaLiver Cancer
- Interventions
- Procedure: CryoablationProcedure: Trans-arterial Catheter Chemoembolization (TACE)Procedure: Radiofrequency Ablation (RFA)
- First Posted Date
- 2016-07-04
- Last Posted Date
- 2023-03-28
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 54
- Registration Number
- NCT02821754
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
MEDI4736 Combinations in Metastatic Renal Cell Carcinoma
- Conditions
- Renal Clear Cell CarcinomaRenal Papillary Cell Carcinoma
- Interventions
- First Posted Date
- 2016-06-30
- Last Posted Date
- 2024-11-04
- Lead Sponsor
- Queen Mary University of London
- Target Recruit Count
- 69
- Registration Number
- NCT02819596
- Locations
- 🇬🇧
Thomas Powles, London, United Kingdom
Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes
- Conditions
- Advanced and/or Metastatic Sarcoma
- Interventions
- First Posted Date
- 2016-06-28
- Last Posted Date
- 2024-06-21
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 56
- Registration Number
- NCT02815995
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery
- Conditions
- HydronephrosisInfiltrating Bladder Urothelial Carcinoma Sarcomatoid VariantInfiltrating Bladder Urothelial Carcinoma, Micropapillary VariantInfiltrating Bladder Urothelial Carcinoma, Plasmacytoid VariantInfiltrating Renal Pelvis Urothelial Carcinoma, Sarcomatoid VariantRenal Pelvis Urothelial CarcinomaStage II Bladder Urothelial Carcinoma AJCC v6 and v7Stage II Renal Pelvis Cancer AJCC v7Stage II Ureter Cancer AJCC v7Stage II Urethral Cancer AJCC v7
- Interventions
- First Posted Date
- 2016-06-24
- Last Posted Date
- 2025-03-25
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 54
- Registration Number
- NCT02812420
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Study of Azacitidine and Durvalumab in Advanced Solid Tumors
- Conditions
- Platinum Resistant Epithelial Ovarian Cancer Type IIEstrogen Receptor Positive and HER2 Negative Breast CancerMicrosatellite Stable Colorectal Carcinoma
- Interventions
- First Posted Date
- 2016-06-23
- Last Posted Date
- 2021-04-01
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 28
- Registration Number
- NCT02811497
- Locations
- 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2016-06-21
- Last Posted Date
- 2023-02-21
- Lead Sponsor
- Celgene
- Target Recruit Count
- 37
- Registration Number
- NCT02807454
- Locations
- 🇺🇸
UCLA Division of Hematology Oncology, Los Angeles, California, United States
🇨🇦Local Institution - 103, Saint John, New Brunswick, Canada
🇨🇦Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
- Conditions
- Advanced Cancer
- Interventions
- First Posted Date
- 2016-06-20
- Last Posted Date
- 2021-04-06
- Lead Sponsor
- Mirati Therapeutics Inc.
- Target Recruit Count
- 83
- Registration Number
- NCT02805660
- Locations
- 🇺🇸
Southern Cancer Center, PC, Mobile, Alabama, United States
🇺🇸David Geffen School of Medicine at UCLA, Los Angeles, California, United States
🇺🇸NorthShore University Health System, Evanston, Illinois, United States
Drug Development Updates
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