Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558214
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
OPTIMUS PRIME Safety and Feasibility of OPTune GIO Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa A randomizEd Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
OPTIMUS PRIME Safety and Feasibility of OPTune GIO Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa A randomizEd Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMUS PRIME
Brief Summary:
In this study we are evaluating the safety and feasibility of the triple combination TTFields MLA pembrolizumab in adult patients diagnosed with recurrent or progressive glioblastoma GBM WHO Grade IV IDH wild type or recurrent or progressive astrocytoma WHO grade IV
Detailed Description:
Twenty patients diagnosed with recurrent or progressive glioblastoma will be enrolled in this pilot study of safety and feasibility and receive the triple combination of Optune GIO MLA and pembrolizumab
Patients will be identified and enrolled prior to initiation of treatment for recurrence and be randomized 11 to each arm has 10 patients
Arm 1 Optune GIO pre-MLA MLA followed by Optune GIO Pembrolizumab post MLA
Arm 2 Optune GIOPembrolizumab pre-MLA MLA followed by Optune GIO Pembrolizumab post MLA
Surgical resectiondebulking is per standard of care and optional for the purpose of this study The performing neurosurgeon will determine whether each patient will undergo surgery For patients who undergo debulking surgery MLA is expected to occur between 3-6 weeks post-surgery when the performing surgeon assesses the procedure is safe
Patients randomized to treatment arm 1 will start treatment with Optune GIO for 3-7 days and undergo MLA and biopsy for tumor diagnosis and immune monitoring Treatment with Optune GIO will be paused prior to the MLA procedure until at least 10 days post MLA Patients will then resume treatment with Optune GIO and receive pembrolizumab 200 mg IV every 3 weeks - 4 days starting no sooner than 1 week after the start of Optune GIO
Patients randomized to treatment arm 2 will start treatment with Optune GIO for 3-10 days and receive one infusion of pembrolizumab before undergoing MLAbiopsy Patients will resume Optune GIO no earlier than 10 days post-surgery and receive pembrolizumab 200 mg IV every 3 weeks - 4 days starting no sooner than 1 week after the start of Optune GIO Post MLA patients may continue treatment with Optune GIO and pembrolizumab for up to 2 years or until disease progression intolerable toxicity whichever comes first
Patients will be identified and enrolled prior to initiation of treatment for recurrence and be randomized 11 to each arm has 10 patients
Arm 1 Optune GIO pre-MLA MLA followed by Optune GIO Pembrolizumab post MLA
Arm 2 Optune GIOPembrolizumab pre-MLA MLA followed by Optune GIO Pembrolizumab post MLA
Surgical resectiondebulking is per standard of care and optional for the purpose of this study The performing neurosurgeon will determine whether each patient will undergo surgery For patients who undergo debulking surgery MLA is expected to occur between 3-6 weeks post-surgery when the performing surgeon assesses the procedure is safe
Patients randomized to treatment arm 1 will start treatment with Optune GIO for 3-7 days and undergo MLA and biopsy for tumor diagnosis and immune monitoring Treatment with Optune GIO will be paused prior to the MLA procedure until at least 10 days post MLA Patients will then resume treatment with Optune GIO and receive pembrolizumab 200 mg IV every 3 weeks - 4 days starting no sooner than 1 week after the start of Optune GIO
Patients randomized to treatment arm 2 will start treatment with Optune GIO for 3-10 days and receive one infusion of pembrolizumab before undergoing MLAbiopsy Patients will resume Optune GIO no earlier than 10 days post-surgery and receive pembrolizumab 200 mg IV every 3 weeks - 4 days starting no sooner than 1 week after the start of Optune GIO Post MLA patients may continue treatment with Optune GIO and pembrolizumab for up to 2 years or until disease progression intolerable toxicity whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None