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 (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

Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-12-07
Last Posted Date
2024-05-21
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
82
Registration Number
NCT03768570
Locations
🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

🇨🇦

Kingston Health Sciences Centre, Kingston, Ontario, Canada

🇨🇦

London Regional Cancer Program, London, Ontario, Canada

and more 28 locations

Durvalumab Plus Tremelimumab for the Treatment of Patients with Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial

First Posted Date
2018-11-27
Last Posted Date
2024-11-11
Lead Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Target Recruit Count
79
Registration Number
NCT03753919
Locations
🇪🇸

Hospital Clínic Barcelona, Barcelona, Spain

🇪🇸

Hospital Universitario Virgen de la Victoria, Málaga, Spain

🇪🇸

Clínica Universidad de Navarra, Pamplona, Spain

and more 12 locations

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

First Posted Date
2018-11-15
Last Posted Date
2024-11-19
Lead Sponsor
AstraZeneca
Target Recruit Count
243
Registration Number
NCT03742102
Locations
🇬🇧

Research Site, Oxford, United Kingdom

PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Chemotherapy Resistant Residual Triple Negative Breast Cancer

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2018-11-14
Last Posted Date
2020-02-21
Lead Sponsor
Institute of Cancer Research, United Kingdom
Target Recruit Count
81
Registration Number
NCT03740893
Locations
🇬🇧

Christie Hospital NHS Trust, Manchester, England, United Kingdom

🇬🇧

Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom

🇬🇧

King's College Hospital, London, England, United Kingdom

and more 6 locations

WIRE - Novel Treatments in Renal Cell Cancer

First Posted Date
2018-11-14
Last Posted Date
2023-06-07
Lead Sponsor
CCTU- Cancer Theme
Target Recruit Count
60
Registration Number
NCT03741426
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

🇬🇧

Beatson Institute for Cancer Research, Glasgow, United Kingdom

Window of Opportunity Trial of Durvalumab (MEDI4736) or Durvalumab/Tremelimumab as Neoadjuvant Chemotherapy to Identify Immune Dynamics in Surgically Resectable Head and Neck Cancer Patients.

First Posted Date
2018-11-13
Last Posted Date
2023-03-21
Lead Sponsor
Yonsei University
Target Recruit Count
48
Registration Number
NCT03737968
Locations
🇰🇷

Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-11-06
Last Posted Date
2024-11-28
Lead Sponsor
AstraZeneca
Target Recruit Count
1063
Registration Number
NCT03732677
Locations
🇻🇳

Research Site, Hochiminh, Vietnam

Trial Evaluating the Tolerance and Safety of Durvalumab - RT Combination for Treatment in SCCHN

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-10-31
Last Posted Date
2024-07-10
Lead Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Target Recruit Count
61
Registration Number
NCT03726775
Locations
🇫🇷

Institut Sainte Catherine, Avignon, France

🇫🇷

Centre Eugene Marquis, Rennes, France

A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-10-16
Last Posted Date
2024-11-06
Lead Sponsor
AstraZeneca
Target Recruit Count
407
Registration Number
NCT03706690
Locations
🇹🇷

Research Site, Malatya, Turkey

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