Date: 2015-01-28
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: AstraZeneca (UK)
Product: durvalumab (MEDI4736) and tremelimumab
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor.
- Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. This antibody is directed against B7-H1, have been shown to block the interaction between B7-H1 and its receptors, PD-1 and CD80 (B7-1). This blockade may help to overcome the immunosuppressive effects of B7-H1 on anti-tumor T cells.
- Tremelimumab is a fully human monoclonal antibody which binds to the protein CTLA-4, expressed on the surface of activated T lymphocytes.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic
area: Cancer - Oncology
Country: Australia, Belgium, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Republic of Korea, Netherlands, Poland, Romania, Russian Federation, Serbia, Singapore, Spain, Taiwan, Thailand, UK, USA, Argentina, Philippines, South Africa, Turkey
Trial
details:
- The ARCTIC study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [Tarceva®]), gemcitabine or vinorelbine (Navelbine®). (NCT02352948 )
Latest
news: * On January 28, 2015, a Phase 3 trial sponsored by AstraZeneca was published on the NIH website ClinicalTrials.gov for durvalumab (MEDI4736) and is currently recruiting participants.
Is
general: Yes
