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

BC3402 w/ Tremelimumab + Durvalumab (STRIDE) in Hepatocellular Carcinoma

Phase 1

Not yet recruiting

Conditions: Hepato Cellular Carcinoma (HCC)

Interventions: Drug: BC3402
Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2024-09-23

Last Posted Date: 2025-01-06

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 43

Registration Number: NCT06608940

Locations: 🇺🇸
Case Comprehensive Cancer Center Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA)

Phase 2

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Oleclumab
Drug: Durvalumab

First Posted Date: 2024-09-23

Last Posted Date: 2025-03-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 28

Registration Number: NCT06606847

Locations: 🇷🇺
Research Site, Ufa, Russian Federation

Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients with Locally Advanced or Metastatic Gallbladder Cancer

Phase 2

Not yet recruiting

Conditions: Gallbladder Cancer Unresectable

Interventions: Drug: gemcitabine hydrochloride
Drug: Cisplatin
Drug: Nab-paclitaxel
Drug: Durvalumab

First Posted Date: 2024-09-11

Last Posted Date: 2024-09-11

Lead Sponsor: Fudan University

Target Recruit Count: 33

Registration Number: NCT06591650

Locations: 🇨🇳
Huashan Hospital, Fudan University, Shanghai, Shanghai, China

Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)

Phase 1

Not yet recruiting

Conditions: Biliary Tract Cancers

Interventions: Drug: mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)]
Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2024-08-21

Last Posted Date: 2025-05-11

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 25

Registration Number: NCT06564623

Locations: 🇺🇸
SKCCC Johns Hopkins Medical Institution, Baltimore, Maryland, United States

A Study of GSK5764227 in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Neoplasms

Interventions: Biological: GSK5764227
Drug: Cisplatin
Drug: Carboplatin
Biological: Atezolizumab
Biological: Pembrolizumab
Biological: Durvalumab
Biological: Cetuximab
Biological: Bevacizumab

First Posted Date: 2024-08-13

Last Posted Date: 2025-03-18

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 281

Registration Number: NCT06551142

Locations: 🇬🇧
GSK Investigational Site, Edinburgh, United Kingdom

CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers

Phase 1

Recruiting

Conditions: Metastatic Biliary Tract Cancer

Interventions: Drug: Gemcitabine
Drug: Cisplatin
Drug: Durvalumab
Drug: CTX-009

First Posted Date: 2024-08-12

Last Posted Date: 2025-04-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 50

Registration Number: NCT06548412

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Chemoimmunotherapy Combined with Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer

Phase 1

Recruiting

Conditions: Biliary Tract Cancer
Cholangiocarcinoma

Interventions: Drug: Gemcitabine
Drug: Cisplatin
Drug: Durvalumab
Radiation: Spatially Fractionated RT
Device: Deep Hyperthermia

First Posted Date: 2024-08-09

Last Posted Date: 2024-11-27

Lead Sponsor: University of Maryland, Baltimore

Target Recruit Count: 15

Registration Number: NCT06546969

Locations: 🇺🇸
Maryland Proton Treatment Center, Baltimore, Maryland, United States
🇺🇸
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States