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

Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer

First Posted Date
2020-05-21
Last Posted Date
2024-04-26
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
20
Registration Number
NCT04397003
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy

First Posted Date
2020-05-13
Last Posted Date
2024-10-10
Lead Sponsor
University of Southern California
Target Recruit Count
10
Registration Number
NCT04387084
Locations
🇺🇸

Los Angeles General Medical Center, Los Angeles, California, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

First Posted Date
2020-05-08
Last Posted Date
2024-11-19
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
870
Registration Number
NCT04380636
Locations
🇺🇸

Torrance Memorial Physician Network / Cancer Center ( Site 0093), Torrance, California, United States

🇺🇸

UCLA Hematology/Oncology - Santa Monica ( Site 0013), Los Angeles, California, United States

🇺🇸

Miami VA Healthcare System ( Site 0024), Miami, Florida, United States

and more 202 locations

Radiomic Signature as Predictive Marker of Response to Chemoradiation and Durvalumab in Stage III NSCLC.

Active, not recruiting
Conditions
First Posted Date
2020-04-28
Last Posted Date
2023-09-28
Lead Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Target Recruit Count
100
Registration Number
NCT04364776
Locations
🇮🇹

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects

Phase 2
Completed
Conditions
Interventions
First Posted Date
2020-04-24
Last Posted Date
2024-01-03
Lead Sponsor
Se-Hoon Lee
Target Recruit Count
42
Registration Number
NCT04361825
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

🇰🇷

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of

Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

First Posted Date
2020-04-22
Last Posted Date
2020-05-27
Lead Sponsor
Hui Bu
Target Recruit Count
30
Registration Number
NCT04356222

DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma

First Posted Date
2020-04-06
Last Posted Date
2024-11-07
Lead Sponsor
PrECOG, LLC.
Target Recruit Count
214
Registration Number
NCT04334759
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

🇺🇸

The Ohio State University, Columbus, Ohio, United States

and more 54 locations

Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma

First Posted Date
2020-03-26
Last Posted Date
2024-01-08
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
4
Registration Number
NCT04322643
Locations
🇺🇸

Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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