Date: 2015-07-13
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: urothelial cancer
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Israel, Italy, Japan, Republic of Korea, Mexico, Netherlands, Poland, Portugal, Russian Federation, Spain, Taiwan, Turkey, UK, USA
Trial
details: This randomized, open-label, controlled, multi-center, global Phase III study is to determine the efficacy and safety of MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus SoC (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) first-line chemotherapy in treatment-naïve patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) and to allow sufficient flexibility for Investigators and patients to select the agents that reflect their normal clinical practice and national guidelines. The patients enrolled in the study will be randomized 1:1:1 to receive treatment with combination therapy, monotherapy, or SoC (cisplatin + gemcitabine or carboplatin + gemcitabine, based on cisplatin eligibility). Patients will be treated with MEDI4736 or MEDI4736 with tremelimumab, or treated with SoC until progressive disease (PD) is confirmed, unacceptable toxicity occurs, withdrawal of consent, or another discontinuation criterion is met. Patients will be followed for up to 2 years. (NCT02516241)
Latest
news: * On July 13, 2015, a Phase 3 trial sponsored by AstraZeneca was published on the NIH website ClinicalTrials.gov for durvalumab (MEDI4736) and tremelimumab and is currently recruiting participants.
