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

Clinical Trials

Multimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC)

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer
NSCLC

Interventions: Drug: Durvalumab
Radiation: Radiotherapy

First Posted Date: 2020-01-29

Last Posted Date: 2024-08-01

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 90

Registration Number: NCT04245514

Locations: 🇨🇭
Kantonsspital - St. Gallen, St. Gallen, Switzerland
🇨🇭
Universitätsspital Zuerich, Zurich, Switzerland
🇨🇭
Kantonsspital Aarau, Aarau, Switzerland

and more 10 locations

Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Phase 2

Recruiting

Conditions: Intrahepatic Cholangiocarcinoma

Interventions: Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2020-01-23

Last Posted Date: 2023-11-18

Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Target Recruit Count: 50

Registration Number: NCT04238637

Locations: 🇩🇪
Hannover Medical School, Hannover, Germany
🇩🇪
Clinic Essen Center, Essen, Germany
🇩🇪
University Hospital Essen, Essen, Germany

and more 5 locations

Intensified Chemo-immuno-radiotherapy With Durvalumab for Stage III Non-Small Cell Lung Cancers

Phase 2

Active, not recruiting

Conditions: Lung Neoplasms

Interventions: Drug: Durvalumab

First Posted Date: 2020-01-18

Last Posted Date: 2023-10-05

Lead Sponsor: Latin American Cooperative Oncology Group

Target Recruit Count: 48

Registration Number: NCT04230408

Locations: 🇧🇷
Beneficiencia Portuguesa de São Paulo/Hospital São José, São Paulo, Brazil
🇧🇷
ICESP, São Paulo, Brazil
🇧🇷
Liga Norte Riograndense Contra o Câncer, Natal, Rio Grande Do Norte, Brazil

and more 3 locations

Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group

Phase 2

Active, not recruiting

Conditions: Anal Cancer
Anal Carcinoma
Anal Cancer Stage III
Anal Cancer Stage II

Interventions: Drug: Chemotherapy
Radiation: Radiation
Drug: Durvalumab

First Posted Date: 2020-01-18

Last Posted Date: 2023-12-04

Lead Sponsor: Goethe University

Target Recruit Count: 180

Registration Number: NCT04230759

Locations: 🇦🇹
Univeritätsklinik für Strahlentherapie-Radioonkologie, Graz, Austria
🇩🇪
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Dresden, Germany
🇩🇪
University Hospital Goethe University Frankfurt, Frankfurt, Germany

and more 22 locations

A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial

Phase 2

Active, not recruiting

Conditions: Bladder Urothelial Carcinoma
Stage III Bladder Cancer AJCC v8

Interventions: Procedure: Biopsy of Bladder
Procedure: Biospecimen Collection
Drug: Cisplatin
Procedure: Computed Tomography
Procedure: Cystoscopy
Biological: Durvalumab
Other: Patient Observation
Drug: Gemcitabine Hydrochloride
Drug: Fluorouracil
Procedure: Magnetic Resonance Imaging
Drug: Mitomycin
Radiation: Radiation Therapy

First Posted Date: 2020-01-02

Last Posted Date: 2024-11-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 95

Registration Number: NCT04216290

Locations: 🇺🇸
Springfield Memorial Hospital, Springfield, Illinois, United States
🇺🇸
Logan Health Medical Center, Kalispell, Montana, United States
🇺🇸
Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States

and more 214 locations

Phase-II Trial of Induction Chemotherapy and Chemoradiotherapy Plus/Minus Durvalumab and Consolidation Immunotherapy in Patients With Resectable Stage III NSCLC.

Phase 2

Recruiting

Conditions: NSCLC, Stage III

Interventions: Drug: Durvalumab

First Posted Date: 2019-12-18

Last Posted Date: 2023-05-10

Lead Sponsor: University Hospital, Essen

Target Recruit Count: 90

Registration Number: NCT04202809

Locations: 🇩🇪
Klinikum rechts der Isar - Technische Universität München, Munich, Bavaria, Germany
🇩🇪
Universitätsklinikum Freiburg, Freiburg, Germany
🇩🇪
Universitätsklinikum Essen, Essen, Germany

and more 4 locations

Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma

Phase 2

Withdrawn

Conditions: Metastatic Cancer
Uveal Melanoma

Interventions: Drug: Cediranib Maleate
Drug: Durvalumab

First Posted Date: 2019-12-03

Last Posted Date: 2020-06-02

Lead Sponsor: Grupo Español Multidisciplinar de Melanoma

Registration Number: NCT04184518

Locations: 🇪🇸
Instituto Catalá d'Oncología L'Hospitalet, L'Hospitalet De Llobregat, Barcelona, Spain
🇪🇸
H. U. Virgen de la Victoria, Málaga, Spain
🇪🇸
H.U. Virgen Macarena, Sevilla, Spain

and more 2 locations

CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: CFI-400945
Drug: Durvalumab

First Posted Date: 2019-11-25

Last Posted Date: 2024-08-09

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 15

Registration Number: NCT04176848

Locations: 🇨🇦
Kingston Health Sciences Centre, Kingston, Ontario, Canada
🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
🇨🇦
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

and more 2 locations