MedPath

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
Clinical Trials
Related News

A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia

Phase 1
Completed
Conditions
Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Interventions
First Posted Date
2016-04-11
Last Posted Date
2023-11-18
Lead Sponsor
Celgene
Target Recruit Count
106
Registration Number
NCT02733042
Locations
🇺🇸

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

🇺🇸

Jefferson Medical Oncology Associates, Philadelphia, Pennsylvania, United States

🇫🇷

Centre Hospitalier Universitaire d'Avicennes, Bobigny Cedex, France

and more 62 locations

Matched Paired Pharmacodynamics and Feasibility Study of Durvalumab in Combination With Chemotherapy in Frontline Ovarian Cancer (N-Dur)

Phase 1
Active, not recruiting
Conditions
Stage III Ovarian Cancer AJCC v6 and v7
Stage III Primary Peritoneal Cancer AJCC v7
Stage IIIA Fallopian Tube Cancer AJCC v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IV Ovarian Cancer AJCC v6 and v7
Stage IIIC Fallopian Tube Cancer AJCC v7
Stage IIIC Primary Peritoneal Cancer AJCC v7
Stage IV Fallopian Tube Cancer AJCC v6 and v7
Stage IV Primary Peritoneal Cancer AJCC v7
Stage III Fallopian Tube Cancer AJCC v7
Interventions
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Quality-of-Life Assessment
First Posted Date
2016-04-04
Last Posted Date
2024-12-06
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
18
Registration Number
NCT02726997
Locations
🇺🇸

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

Pilot Study of Durvalumab and Vigil in Advanced Women's Cancers

Phase 2
Completed
Conditions
Primary Peritoneal Carcinoma
Ovarian Cancer
Uterine Cancer
Cervical Cancer
Fallopian Tube Cancer
Breast Cancer
Endometrial Cancer
Interventions
Biological: Vigil
First Posted Date
2016-04-01
Last Posted Date
2021-01-27
Lead Sponsor
Mary Crowley Medical Research Center
Target Recruit Count
13
Registration Number
NCT02725489
Locations
🇺🇸

Mary Crowley Cancer Research Center, Dallas, Texas, United States

A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors

Phase 1
Completed
Conditions
Solid Tumor
Interventions
First Posted Date
2016-03-24
Last Posted Date
2023-10-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
72
Registration Number
NCT02718911
Locations
🇺🇸

Sarah Cannon Cancer Center, Nashville, Tennessee, United States

🇺🇸

Tennessee Oncology PLLC, Nashville, Tennessee, United States

🇧🇪

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

and more 11 locations

Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant

Phase 1
Terminated
Conditions
Multiple Myeloma
Interventions
Biological: Prevnar-13
First Posted Date
2016-03-23
Last Posted Date
2022-10-12
Lead Sponsor
Ludwig Institute for Cancer Research
Target Recruit Count
6
Registration Number
NCT02716805
Locations
🇺🇸

Research Facility, New York, New York, United States

A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma

Phase 1
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2016-02-19
Last Posted Date
2023-10-06
Lead Sponsor
Celgene
Target Recruit Count
56
Registration Number
NCT02685826
Locations
🇺🇸

Swedish Medical Center, Seattle, Washington, United States

🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

🇨🇦

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

and more 51 locations

A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors

Phase 1
Active, not recruiting
Conditions
Advanced Solid Tumors
Interventions
Drug: mFOLFOX6
First Posted Date
2016-02-02
Last Posted Date
2025-04-22
Lead Sponsor
MedImmune LLC
Target Recruit Count
383
Registration Number
NCT02671435
Locations
🇬🇧

Research Site, Sutton, United Kingdom

MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors

Phase 2
Terminated
Conditions
Non-Small Cell Lung Cancer
Nonsmall Cell Lung Cancer
Breast Cancer
Cancer of Breast
Cancer of the Breast
Gastroesophageal Cancer
Pancreatic Cancer
Cancer of the Pancreas
Colorectal Cancer
Colorectal Carcinoma
Interventions
First Posted Date
2016-02-01
Last Posted Date
2018-11-06
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
4
Registration Number
NCT02669914
Locations
🇺🇸

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

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

Phase 2
Active, not recruiting
Conditions
Adenocarcinoma
Non-Small Cell Lung Cancer
Carcinoma, Squamous Cell
Interventions
First Posted Date
2016-01-27
Last Posted Date
2025-05-21
Lead Sponsor
University of Birmingham
Target Recruit Count
423
Registration Number
NCT02664935
Locations
🇬🇧

Royal Devon and Exeter Hospital, Exeter, United Kingdom

🇬🇧

University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom

🇬🇧

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom

and more 22 locations

Durvalumab in Patients With HER-2 Positive Metastatic Breast Cancer Receiving Trastuzumab

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2016-01-07
Last Posted Date
2023-08-04
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
15
Registration Number
NCT02649686
Locations
🇨🇦

University Health Network, Toronto, Ontario, Canada

🇨🇦

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

🇨🇦

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

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