Date: 2016-03-03
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Merck&Co (USA - NJ)
Product: Keytruda® (pembrolizumab - MK-3475)
Action
mechanism: monoclonal antibody./immune checkpoint inhibitor. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. In April 2013, MK-3475 has received a Breakthrough Therapy designation for advanced melanoma from the FDA. In October 2014, the FDA has gralso anted Breakthrough Therapy Designation to Keytruda® (pembrolizumab) for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. In November 2015, the FDA has granted Breakthrough Therapy Designation to Keytruda® for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway. The Keytruda® clinical development program includes patients with more than 30 tumor types in more than 160 clinical trials, including more than 80 trials that combine Keytruda® with other cancer treatments. Registration-enabling trials of Keytruda® are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, Hodgkin lymphoma, multiple myeloma and other tumors, with further trials in planning for other cancers.
Disease: hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Canada, France, Germany, Italy, Japan, Sweden, UK, USA
Trial
details: This phase 2 study is a efficacy and safety study of pembrolizumab (MK-3475, KEYTRUDA®) as monotherapy in participants with previously systemically treated hepatocellular carcinoma (HCC). Study participants may receive pembrolizumab once every 3 weeks for up to 35 administrations (up to approximately 2 years). The primary objective of this study is to determine the Objective Response Rate (ORR) of pembrolizumab given as monotherapy in participants with previously systemically treated HCC. (NCT02702414)
Latest
news: * On March 3, 2016, a Phase I trial sponsored by Merck&Co was published on the NIH website ClinicalTrials.gov for Keytruda® (pembrolizumab - MK-3475) and is currently recruiting participants.
