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PD-1 Inhibitor

Suppressor of the PI3K/Akt pathways for Glioblastoma

Phase 1 & 2
Waitlist Available
Led By Jann Lee, PhD
Research Sponsored by Medical Research Council
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: 12 months
Awards & highlights

Study 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).

Eligible Conditions
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Safety and tolerability of Pembrolizumab (Assessed by reported adverse events using CTCAE version 4.0)
Other outcome measures
Safety and tolerability of inhibitors PI3K/Akt pathways as monotherapy (adverse events using CTCAE version 4.0)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Suppressor of the PI3K/Akt pathwaysExperimental Treatment1 Intervention
Pictilisib (GDC-0941) is a potent inhibitor of PI3Kα/δ. Patients will take the Pictilisib (capsules) orally with food. The dose should be taken every 3 weeks. BEZ235 (NVP-BEZ235) is a dual ATP-competitive PI3K and mTOR inhibitor. Inhibits ATR whileshown to be a poor inhibitor to Akt and PDK1. Patients will take the BEZ235 (capsules) orally with food. The dose should be taken every 3 weeks. Ipatasertib (GDC-0068) is a highly selective pan-Akt inhibitor targeting Akt1/2/3 . Patients will take the Ipatasertib (capsules) orally with food. The dose should be taken every 3 weeks. The suggested dosage of inhibitors of the PI3K/Akt pathway orally as a single dose in capsule and Packed in plastic boxes, so that preparations can be taken at home
Group II: MK-3475Active Control1 Intervention
Pembrolizumab (MK-3475) is a humanized monoclonal antibody. Information from these studies suggests that Pembrolizumab (MK-3475) may be beneficial in Glioblastoma / Gliosarcoma. Patients enrolling in phase 1 receive MK-3475 every 3 weeks, with the dose to be determined. MK-3475 will be given intravenously over the course of 30 minutes

Find a Location

Who is running the clinical trial?

Medical Research CouncilLead Sponsor
315 Previous Clinical Trials
1,962,839 Total Patients Enrolled
NCRI Clinical Studies GroupsUNKNOWN
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,660 Total Patients Enrolled
30 Trials studying Glioblastoma
2,993 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475
Ms. Jann Lee 2013. "Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02430363.
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