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

Durvalumab and Consolidation SBRT Following Chemoradiation for Locally Advanced Stage III Non-Small Cell Lung

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-07-18
Last Posted Date
2024-02-20
Lead Sponsor
Brown University
Target Recruit Count
11
Registration Number
NCT03589547
Locations
🇺🇸

The Miriam Hospital, Providence, Rhode Island, United States

🇺🇸

Rhode Island Hospital, Providence, Rhode Island, United States

Chemoradiation With Durvalumab Followed by Durvalumab Maintenance for Limited Disease Small Cell Lung Cancer

Phase 2
Conditions
Interventions
First Posted Date
2018-07-13
Last Posted Date
2020-03-02
Lead Sponsor
Samsung Medical Center
Target Recruit Count
51
Registration Number
NCT03585998
Locations
🇰🇷

Samsung Medical Center, Seoul, MA, Korea, Republic of

Durvalumab, Tremelimumab, and Selumetinib in Treating Participants With Recurrent or Stage IV Non-small Cell Lung Cancer

First Posted Date
2018-07-10
Last Posted Date
2024-12-05
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
40
Registration Number
NCT03581487
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-07-09
Last Posted Date
2024-04-19
Lead Sponsor
Do-Youn Oh
Target Recruit Count
40
Registration Number
NCT03579784
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-06-28
Last Posted Date
2024-04-19
Lead Sponsor
Do-Youn Oh
Target Recruit Count
71
Registration Number
NCT03572400
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma

First Posted Date
2018-06-08
Last Posted Date
2024-03-06
Lead Sponsor
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Target Recruit Count
121
Registration Number
NCT03549715
Locations
🇫🇷

Institut Paoli Calmettes, Marseille, France

🇫🇷

Centre Eugène Marquis, Rennes, France

🇫🇷

Groupe Hospitalier Pitié-Salpetrière, Paris, France

and more 12 locations

Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies

First Posted Date
2018-05-29
Last Posted Date
2024-06-07
Lead Sponsor
Anwaar Saeed
Target Recruit Count
117
Registration Number
NCT03539822
Locations
🇺🇸

University of Kansas Cancer Center, Westwood, Kansas, United States

🇺🇸

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Durvalumab Plus Olaparib Administered Prior to Surgery of Resectable Urothelial Bladder Cancer (NEODURVARIB)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-05-23
Last Posted Date
2020-04-06
Lead Sponsor
Spanish Oncology Genito-Urinary Group
Target Recruit Count
29
Registration Number
NCT03534492
Locations
🇪🇸

Clinica IMQ Zorrotzaurre, Bilbao, Spain

🇪🇸

ICO Badalona, Badalona, Barcelona, Spain

🇪🇸

Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain

and more 7 locations

Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

First Posted Date
2018-05-18
Last Posted Date
2024-07-16
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
18
Registration Number
NCT03529422
Locations
🇺🇸

University Of Alabama At Birmingham, Birmingham, Alabama, United States

🇺🇸

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

🇺🇸

Medical University of South Carolina - Hollings Cancer Center, Charleston, South Carolina, United States

Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

First Posted Date
2018-05-09
Last Posted Date
2024-05-24
Lead Sponsor
AstraZeneca
Target Recruit Count
328
Registration Number
NCT03519971
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

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