Date: 2014-01-14
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Merck KGaA (Germany)
Product: avelumab (MSB0010718C)
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth. Pfizer and Merck KGaA are jointly developing avelumab (MSB0010718C), an investigational anti-PD-L1 antibody currently in development by Merck KGaA as a potential treatment for multiple types of cancer.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: Belgium, Czech Republic, France, Germany, Hungary, Korea, Republic of, Poland, Taiwan, UK, USA
Trial
details: This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Renal cell carcinoma (RCC, first line). Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy) and gastric/gastroesophageal junction (GEJ) cancer (third line). (NCT01772004)
Latest
news: * On January 14, 2014, a Phase I trial sponsored by Merck KGaA was published on the NIH website ClinicalTrials.gov for avelumab and is currently recruiting participants.
