Date: 2015-07-29
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Eisai (Japan) Merck&Co (USA - NJ)
Product: Keytruda® (pembrolizumab) and Halaven® (eribulin)
Action
mechanism: microtubule inhibitor/monoclonal antibody/immune checkpoint inhibitor. Halaven® is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. It belongs to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequestering tubulin into nonproductive aggregates. Keytruda® (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2.
Disease: triple-negative breast cancer (TNBC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in combination with pembrolizumab in subjects with metastatic triple-negative breast cancer previously treated with 0 to 2 chemotherapy regimens in the metastatic setting. (NCT02513472)
Latest
news: * On July 29, 2015, a Phase 1-2 trial sponsored by Eisai and Merck&Co was published on the NIH website ClinicalTrials.gov for pembrolizumab and eribulin and is currently recruiting participants. (Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC)