NCT02430363

Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475

Phase IIb Trial Evaluations Of The Effectiveness Of Treatment Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475 (Pembrolizumab)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is known that after application of MK-3475 activated PD -1 negatively regulates the activation of T cells through suppression of the path of PI3K / Akt. This study will identify the effectiveness of oral inhibitors of PI3K / Akt pathway in comparison with MK-3475 (pembrolizumab).

Detailed description

A humanized monoclonal IgG4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immunopotentiating activity. Upon administration, pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells. The ligands for PD-1 include PD-L1, which is expressed on antigen presenting cells (APCs) and overexpressed on certain cancer cells, and PD-L2, which is primarily expressed on APCs. Activated PD-1 negatively regulates T-cell activation through the suppression of the PI3K/Akt pathway. This study will identify the effectiveness of oral inhibitors of PI3K / Akt pathway in comparison with MK-3475 (pembrolizumab).

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	MK - 3475	Administered Intravenously
BIOLOGICAL	Suppressor of the PI3K/Akt pathways	Capsules orally with food

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-01-01
• Completion: 2018-06-01
• First posted: 2015-04-30
• Last updated: 2016-02-24

Locations

13 sites across 10 countries: United States, Belgium, Germany, Italy, Poland, Russia, Spain, Switzerland, Ukraine, United Kingdom