Trial intelligence / Profile preview

BreakVax Combination Immunotherapy in Glioblastoma

NCT07762716Phase 2

Key facts

Status: Not yet recruiting
Start: Sep 2026
Primary completion: Sep 2030
Countries: 1
Sponsor: BreakBio Corp.

Drugs: BreakVax
Conditions: glioblastoma (GBM)

Overview

Phase 2, open-label, single-arm trial of BreakVax in glioblastoma (GBM), sponsored by BreakBio Corp. Primary endpoints: Overall Survival at 12 months, Percentage of patients for whom BreakVax is successfully manufactured at 24 months and 1 more. Planned start Sep 2026; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

BreakVax Arm
BreakVax + ipilimumab + pembrolizumab + temozolomide + losartan + aspirin

Who it enrols

Adults under 72 with histologically confirmed Glioblastoma, KPS >= 80, adequate organ function, and life expectancy > 6 months. Excludes patients with prior anti-PD-1/PD-L1 therapy, recent immunosuppressive therapy, dMMR/MSI-H phenotype, POLE mutations, or significant cardiovascular/autoimmune diseases.

Endpoints

Primary

Overall Survival12 months
Percentage of patients for whom BreakVax is successfully manufactured24 months
Adverse events24 months

Secondary

T-cell infiltrationCycle 2
Immune-related Objective Response Rateup to 2 years
Progression-Free Survivalup to 2 years
Duration of Responseup to 2 years
Clinical Benefit Rateup to 2 years
Objective Response Rateup to 2 years
Immune-related Progression-Free Survivalup to 2 years
Incidence of Pseudoprogressionup to 2 years

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