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T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus \[CMV\]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4.
Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.
Study details:
This is a multi-centre, non-randomised, open-label, dose escalation and expansion trial of allogeneic cytomegalovirus (CMV)-specific T cells as monotherapy and in combination with pembrolizumab in participants with recurrent and newly diagnosed glioblastoma multiforme (GBM)/astrocytoma grade 4. The trial will be conducted in two parts. Part 1 is a single-arm, sequential 3+3 dose-escalation of allogeneic CMV-specific T cells as a monotherapy and in combination with a fixed dose of pembrolizumab to determine the recommended dose(s) for future exploration.
Up to 18 participants will be recruited for part 1. Part 2 will involve two arms and will examine the clinical impact of the CMV-specific T cells as monotherapy and in combination with pembrolizumab. Forty participants will be recruited for part 2 - 20 with newly diagnosed GBM/astrocytoma grade 4 and 20 with recurrent GBM/astrocytoma grade 4.
Part 2 will only be initiated if the data and safety monitoring board (DSMB) determines that the proposed dose level(s) for future exploration are safe and well tolerated. Additional groups may be explored depending on emergent safety, pharmacodynamics and/or clinical efficacy data. Following screening and enrolment, each participant will receive four weekly infusions (Q1W) of allogeneic CMV-specific T cells, followed by up to 18 infusions of pembrolizumab.
Pembrolizumab infusions will commence seven days (±3 days) after the final T-cell infusion, and be administered every 6 weeks (Q6W). The total duration of participation for each participant is approximately 26 months. Efficacy of the combination therapy will be evaluated according to the modified Response Assessment in Neuro-Oncology (RANO) and immunotherapy (i)RANO criteria, through radiographic imaging.
For group A and group B the appropriate measures for progression-free survival (PFS), overall survival (OS), disease control rate and duration of response will be assessed.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-02-08
Primary completion: 2026-04-01
Study completion finish: 2028-01-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06157541
Intervention or treatment
BIOLOGICAL: Allogeneic cytomegalovirus-specific T cells
DRUG: Pembrolizumab
Conditions
- • Glioblastoma Multiforme
- • Astrocytoma, Grade IV
Find a site
Closest Location:
Royal Brisbane and Women's Hospital
Research sites nearby
Select from list below to view details:
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Newro Foundation
Bowen Hills, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part 1
| BIOLOGICAL: Allogeneic cytomegalovirus-specific T cells
|
EXPERIMENTAL: Part 2 Group A
| BIOLOGICAL: Allogeneic cytomegalovirus-specific T cells
|
EXPERIMENTAL: Part 2 Group B
| BIOLOGICAL: Allogeneic cytomegalovirus-specific T cells
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of dose-limiting toxicities | Part 1 - Primary Endpoint 1 | Within 49 days of receiving the first dose of study drug |
Incidence of adverse events and clinically significant changes in laboratory parameters, vital signs, and electrocardiograms (ECGs) | Part 1 - Primary Endpoint 2 | Within 49 days of the first dose of study drug |
Percentage of participants with confirmed complete response (CR) or partial response (PR) | Part 2 - Primary Endpoint 1 | Within 25 months of the first dose of study drug |
Percentage of participants with confirmed complete response (CR), partial response (PR), or stable disease (SD) | Part 2 - Primary Endpoint 2 | Within 25 months of the first dose of study drug |
Duration of response | Part 2 - Primary Endpoint 3 | Within 25 months of the first dose of study drug |
Overall survival (percentage of participants alive) | Part 2 - Primary Endpoint 4 | 6 months |
Progression-free survival (percentage of participants with no evidence of further disease progression) | Part 2 - Primary Endpoint 5 | 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Percentage of participants with confirmed CR or PR | Part 1 - Secondary Endpoint 1 | Within 25 months of the first dose of study drug |
Percentage of participants with confirmed CR, PR, or SD | Part 1 - Secondary Endpoint 2 | Within 25 months of the first dose of study drug |
Duration of response | Part 1 - Secondary Endpoint 3 | Within 25 months of the first dose of study drug |
Overall survival (percentage of participants alive) | Part 1 - Secondary Endpoint 4 | 6 months |
Progression-free survival (percentage of participants with no evidence of further disease progression) | Part 1 - Secondary Endpoint 5 | 6 months |
Incidence of adverse events and clinically significant changes in laboratory parameters, vital signs, and ECGs | Part 2 - Secondary Endpoint 1 | Within 25 months of the first dose of study drug |
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