Date: 2017-02-08
Type of
information: Initiation of the trial
phase: 1b-2
Announcement: initiation of the trial
Company: BMS (USA - NY)
Product: Opdivo® (nivolumab)+Yervoy® (ipilimumab)
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor . Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them. Opdivo® is the world’s first approved drug targeting PD-1. This monoclonal antibody has been generated under a research collaboration entered into in May 2005 between Ono and Medarex. When Medarex was acquired by BMS in 2009, it also granted BMS its rights to develop and commercialize the anti-human PD-1 monoclonal antibody in North America. Through the collaboration agreement entered into in September 2011 between Ono and BMS, Ono granted BMS exclusive rights to develop and commercialize Opdivo® in the rest of the world, except in Japan, Korea and Taiwan where Ono has retained all rights to develop and commercialize the compound.
- Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses.
Disease: non-small cell lung cancer
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
- CheckMate 955 (CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955) is a phase 1b/2 safety trial of nivolumab in combination with ipilimumab administered in participants with chemotherapy-naive stage IV or recurrent non-small cell lung cancer (NSCLC). (NCT03048136)
Latest
news:
- • On February 8, 2017, a Phase 1b-2 trial sponsored by BMS was published on the NIH website ClinicalTrials.gov for nivolumab and ipilimumab.
Is
general: Yes
