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
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
- Conditions
- Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
- Interventions
- First Posted Date
- 2024-07-15
- Last Posted Date
- 2025-04-08
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Target Recruit Count
- 52
- Registration Number
- NCT06501625
- Locations
- 🇺🇸
Northwestern Medicine, Chicago, Illinois, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Gibbs Cancer Center, Spartanburg, South Carolina, United States
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
- Conditions
- Lung Non-Small Cell CarcinomaStage IIIB Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: Patient ObservationOther: Questionnaire Administration
- First Posted Date
- 2024-07-12
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 306
- Registration Number
- NCT06498635
- Locations
- 🇺🇸
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, United States
🇺🇸Hartford Hospital, Hartford, Connecticut, United States
🇺🇸Midstate Medical Center, Meriden, Connecticut, United States
Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC
- Conditions
- Biliary Tract Cancer
- Interventions
- First Posted Date
- 2024-07-08
- Last Posted Date
- 2024-07-08
- Target Recruit Count
- 40
- Registration Number
- NCT06490107
- Locations
- 🇨🇳
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China
IMPT Dose Escalation for NSCLC (HyDose)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Radiation: Standard-dose intensity-modulated proton therapy (IMPT-60)Radiation: Dose-escalated intensity-modulated proton therapy (IMPT-74)
- First Posted Date
- 2024-07-03
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- University Medical Center Groningen
- Target Recruit Count
- 110
- Registration Number
- NCT06484491
- Locations
- 🇳🇱
UMCG, Groningen, Netherlands
Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
- Conditions
- Advanced Hepatocellular Carcinoma
- Interventions
- First Posted Date
- 2024-06-24
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- Zhiyong Huang
- Target Recruit Count
- 50
- Registration Number
- NCT06470256
- Locations
- 🇨🇳
Tongji Hospital, Wuhan, Hubei, China
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
- Conditions
- Biliary Tract Cancer
- Interventions
- Diagnostic Test: Agilent HercepTest™ mAb pharmDxDiagnostic Test: Ventana PD-L1 SP263 assay
- First Posted Date
- 2024-06-21
- Last Posted Date
- 2025-04-30
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 620
- Registration Number
- NCT06467357
- Locations
- 🇻🇳
Research Site, Vinh, Vietnam
AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA
- First Posted Date
- 2024-06-18
- Last Posted Date
- 2024-06-18
- Lead Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Target Recruit Count
- 66
- Registration Number
- NCT06464068
- Locations
- 🇮🇹
AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
- Conditions
- Unresectable Perihilar or Ductal CCAExtrahepatic Cholangiocarcinoma
- Interventions
- First Posted Date
- 2024-06-04
- Last Posted Date
- 2024-06-04
- Lead Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Target Recruit Count
- 42
- Registration Number
- NCT06440993
- Locations
- 🇩🇪
Krankenhaus Nordwest, Frankfurt, Germany
🇩🇪Universitätsklinikum Düsseldorf, Düsseldorf, Germany
🇩🇪Universitätsklinikum Köln, Köln, Germany
Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP)
- First Posted Date
- 2024-06-04
- Last Posted Date
- 2025-01-15
- Lead Sponsor
- Australasian Gastro-Intestinal Trials Group
- Target Recruit Count
- 40
- Registration Number
- NCT06441747
- Locations
- 🇦🇺
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
🇦🇺Monash Medical Centre, Clayton, New South Wales, Australia
🇦🇺Westmead Hospital, Westmead, New South Wales, Australia
Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)
- First Posted Date
- 2024-05-17
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- University of Cologne
- Target Recruit Count
- 29
- Registration Number
- NCT06419179
- Locations
- 🇩🇪
University Hospital Cologne, Cologne, North Rhine-Westphalia, Germany
Drug Development Updates
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