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 (IgG1ΞΊ) 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 β₯ 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 Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies
- First Posted Date
- 2017-10-16
- Last Posted Date
- 2024-04-04
- Lead Sponsor
- Celgene
- Target Recruit Count
- 62
- Registration Number
- NCT03310619
- Locations
- πΊπΈ
Local Institution - 015, Omaha, Nebraska, United States
πΊπΈLocal Institution - 016, Philadelphia, Pennsylvania, United States
πΊπΈLocal Institution - 011, Duarte, California, United States
Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-10-12
- Last Posted Date
- 2022-02-17
- Lead Sponsor
- Ajjai Alva, MD
- Target Recruit Count
- 57
- Registration Number
- NCT03308396
- Locations
- πΊπΈ
Penn State Cancer Institute, Hershey, Pennsylvania, United States
πΊπΈUniversity of Iowa Hosptials and Clinics, Iowa City, Iowa, United States
πΊπΈUniverisity of Illinois Cancer Center, Chicago, Illinois, United States
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2017-10-02
- Last Posted Date
- 2024-04-25
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1324
- Registration Number
- NCT03298451
- Locations
- π»π³
Research Site, Hochiminh, Vietnam
Renal Adjuvant MultiPle Arm Randomised Trial
- First Posted Date
- 2017-09-20
- Last Posted Date
- 2020-09-07
- Lead Sponsor
- University College, London
- Target Recruit Count
- 1750
- Registration Number
- NCT03288532
- Locations
- π¬π§
The Christie, Manchester, United Kingdom
π¬π§Royal Marsden Hospital, Sutton, United Kingdom
π¬π§Aberdeen Royal Infirmary, Aberdeen, United Kingdom
PDL-1 Inhibition and Focal Sensitizing Radiotherapy in Recurrent Ovarian/Primary Peritoneal/Fallopian Tube Cancers.
- Conditions
- Interventions
- First Posted Date
- 2017-09-15
- Last Posted Date
- 2018-07-11
- Lead Sponsor
- British Columbia Cancer Agency
- Target Recruit Count
- 22
- Registration Number
- NCT03283943
- Locations
- π¨π¦
BC Cancer Agency, Vancouver, British Columbia, Canada
Immunotherapy and SBRT for Metastatic Head and Neck Carcinomas
- Conditions
- Interventions
- First Posted Date
- 2017-09-14
- Last Posted Date
- 2024-06-28
- Target Recruit Count
- 45
- Registration Number
- NCT03283605
- Locations
- π¨π¦
Cross Cancer Institute, Edmonton, Alberta, Canada
π¨π¦London Regional Cancer Program of the Lawson Health Research Institute, London, Ontario, Canada
π¨π¦Centre Hospitalier de l'UniversitΓ© de MontrΓ©al, MontrΓ©al, Quebec, Canada
Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-09-11
- Last Posted Date
- 2023-08-01
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 16
- Registration Number
- NCT03277482
- Locations
- πΊπΈ
Martin King, Boston, Massachusetts, United States
Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition
- Conditions
- Interventions
- First Posted Date
- 2017-09-07
- Last Posted Date
- 2023-05-15
- Lead Sponsor
- University of Wisconsin, Madison
- Target Recruit Count
- 17
- Registration Number
- NCT03275597
- Locations
- πΊπΈ
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
- Conditions
- Oropharyngeal Squamous Cell CarcinomaStage III Lip and Oral Cavity Cancer AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Head and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of Unknown PrimaryStage IVA Hypopharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Interventions
- First Posted Date
- 2017-08-23
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 196
- Registration Number
- NCT03258554
- Locations
- πΊπΈ
Mayo Clinic in Rochester, Rochester, Minnesota, United States
πΊπΈCoborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
πΊπΈSpringfield Memorial Hospital, Springfield, Illinois, United States
Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
- First Posted Date
- 2017-08-23
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 15
- Registration Number
- NCT03258593
- Locations
- πΊπΈ
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Drug Development Updates
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