Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06157541
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-11-26
Brief Title:
T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
Sponsor:
Queensland Institute of Medical Research
Organization:
Queensland Institute of Medical Research
Study Overview
Official Title:
Phase III Clinical Trial of Allogeneic Cytomegalovirus-specific T Cells in Combination With Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma Multiforme
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCaP
Brief Summary:
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 multiformeastrocytoma grade 4
The purpose of part 1 of this study is to determine the maximum-tolerated dose andor recommended doses for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBMastrocytoma 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 GBMgrade 4 astrocytoma
The purpose of part 1 of this study is to determine the maximum-tolerated dose andor recommended doses for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBMastrocytoma 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 GBMgrade 4 astrocytoma
Detailed Description:
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 GBMastrocytoma grade 4 The trial will be conducted in two parts
Part 1 is a single-arm sequential 33 dose-escalation of allogeneic CMV-specific T cells as a monotherapy and in combination with a fixed dose of pembrolizumab to determine the recommended doses 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 GBMastrocytoma grade 4 and 20 with recurrent GBMastrocytoma grade 4
Part 2 will only be initiated if the data and safety monitoring board DSMB determines that the proposed dose levels for future exploration are safe and well tolerated Additional groups may be explored depending on emergent safety pharmacodynamics andor 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 iRANO 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
Part 1 is a single-arm sequential 33 dose-escalation of allogeneic CMV-specific T cells as a monotherapy and in combination with a fixed dose of pembrolizumab to determine the recommended doses 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 GBMastrocytoma grade 4 and 20 with recurrent GBMastrocytoma grade 4
Part 2 will only be initiated if the data and safety monitoring board DSMB determines that the proposed dose levels for future exploration are safe and well tolerated Additional groups may be explored depending on emergent safety pharmacodynamics andor 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 iRANO 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None