Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02287428
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2014-10-29
Brief Title:
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Study of a Personalized NeoAntigen Cancer Vaccine With Radiotherapy Plus PembrolizumabMK-3475 Among Newly Diagnosed Glioblastoma Patients
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:
None
Brief Summary:
This research study is studying a new type of vaccine as a possible treatment for patients with glioblastoma This research study is a Phase I clinical trial which tests the safety of an investigational intervention and also tries to define the appropriate dose of the intervention to use for further studies Investigational means that the intervention is being studied and that research doctors are trying to find more about it It also means that the FDA US Food and Drug Administration has not approved the Personalized NeoAntigen Cancer Vaccine for any use in patients including people with glioblastoma
The purpose of the initial study cohort Cohort 1 is to determine if it is possible to make and administer safely a vaccine against glioblastoma by using information gained from specific characteristics of the participants tumor It is known that glioblastomas have mutations changes in genetic material that are specific to an individual patients tumor These mutations can cause the tumor cells to produce proteins that appear very different from the bodys own cells It is possible that these proteins used in a vaccine may induce strong immune responses which may help the body fight any tumor cells that could cause the glioblastoma to come back in the future
Three additional cohorts 1a 1b 1c were added to the study following completion of accrual to the original study cohort cohort 1 Each new cohort receives NeoVax and radiation therapy as administered to cohort 1 and will also receive pembrolizumab cohort 1a patients will start pembrolizumab win 2 weeks after start of RT and continue every 3 weeks for up to 2 years cohort 1b patients will start pembrolizumab 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years cohort 1c patients will receive a single dose of pembrolizumab administered within 2 weeks after start of RT re-start 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years The rationale for adding these new cohorts is 1 to assess the safety and feasibility of NeoVax when administered with pembrolizumab and 2 to determine if the timing of anti-PD-1 administration impacts the immunogenicity of NeoVax
An additional sub-study cohort 1d is being added for patients whose tumor is MGMT-methylated Cohort 1d will enroll patients with tumors for which the MGMT status is methylated or partially methylated patients on cohort 1d will receive standard daily temozolomide during radiation and as adjuvant therapy for up to six cycles following completion of radiation therapy The rationale for adding cohort 1d is to determine the safety and feasibility of NeoVax when administered with pembrolizumab and temozolomide
The purpose of the initial study cohort Cohort 1 is to determine if it is possible to make and administer safely a vaccine against glioblastoma by using information gained from specific characteristics of the participants tumor It is known that glioblastomas have mutations changes in genetic material that are specific to an individual patients tumor These mutations can cause the tumor cells to produce proteins that appear very different from the bodys own cells It is possible that these proteins used in a vaccine may induce strong immune responses which may help the body fight any tumor cells that could cause the glioblastoma to come back in the future
Three additional cohorts 1a 1b 1c were added to the study following completion of accrual to the original study cohort cohort 1 Each new cohort receives NeoVax and radiation therapy as administered to cohort 1 and will also receive pembrolizumab cohort 1a patients will start pembrolizumab win 2 weeks after start of RT and continue every 3 weeks for up to 2 years cohort 1b patients will start pembrolizumab 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years cohort 1c patients will receive a single dose of pembrolizumab administered within 2 weeks after start of RT re-start 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years The rationale for adding these new cohorts is 1 to assess the safety and feasibility of NeoVax when administered with pembrolizumab and 2 to determine if the timing of anti-PD-1 administration impacts the immunogenicity of NeoVax
An additional sub-study cohort 1d is being added for patients whose tumor is MGMT-methylated Cohort 1d will enroll patients with tumors for which the MGMT status is methylated or partially methylated patients on cohort 1d will receive standard daily temozolomide during radiation and as adjuvant therapy for up to six cycles following completion of radiation therapy The rationale for adding cohort 1d is to determine the safety and feasibility of NeoVax when administered with pembrolizumab and temozolomide
Detailed Description:
It is known that glioblastomas have mutations that are specific to an individual patients tumor These mutations can cause the tumor cells to produce proteins that appear very different from the bodys own cells It is possible that these proteins used in a vaccine may induce strong immune responses which may help the body fight any tumor cells that could cause glioblastoma to recur
Methylguanine methyltransferase MGMT is a DNA repair protein which can be increased in some cancers including glioblastoma MGMT works to repair the DNA of cancer cells that are damaged by treatment If a tumor is found to be unmethylated it means there is more MGMT present in the tumor than one that is methylated
Methylation of MGMT is believed to make tumor cells more responsive to drugs like temozolomide Studies have shown that temozolomide provides a very small improvement in outcome for many patients whose glioblastoma is MGMT-unmethylated
Patients with glioblastoma usually receive six weeks of radiation with a daily chemotherapy called temozolomide after their surgery followed by six to twelve months of additional temozolomide In this study only participants whose tumors are MGMT-methylated will receive temozolomide those participants whose tumors are MGMT-unmethylated will not receive temozolomide as studies have shown that temozolomide provides a very small improvement in outcome for many patients whose glioblastoma is MGMT-unmethylated
On this trial an initial cohort of participants Cohort 1 will receive the Personalized NeoAntigen Vaccine 5 priming doses and 2 booster doses over 20 weeks after having completed six weeks of standard radiation The study will examine the safety of the vaccine when given at several different time points and will examine the participant blood cells for signs that the vaccine induced an immune response
Three additional cohorts 1a 1b 1c were added to the study following completion of accrual to the original study cohort cohort 1 Each new cohort receives NeoVax and radiation therapy as administered to cohort 1 and will also receive pembrolizumab cohort 1a patients will start pembrolizumab win 2 weeks after start of RT and continue every 3 weeks for up to 2 years cohort 1b patients will start pembrolizumab 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years cohort 1c patients will receive a single dose of pembrolizumab administered within 2 weeks after start of RT re-start 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years
The rationale for adding cohorts 1a 1b and 1c is 1 to assess the safety and feasibility of NeoVax when administered with pembrolizumab and 2 to determine if the timing of anti-PD-1 administration impacts the immunogenicity of NeoVax
An additional sub-study cohort 1d is being added for patients whose tumor is MGMT-methylated Cohort 1d will enroll patients with tumors for which the MGMT status is methylated or partially methylated patients on cohort 1d will receive standard daily temozolomide during radiation and as adjuvant therapy for up to six cycles following completion of radiation therapy The rationale for adding cohort 1d is to determine the safety and feasibility of NeoVax when administered with pembrolizumab and temozolomide
Methylguanine methyltransferase MGMT is a DNA repair protein which can be increased in some cancers including glioblastoma MGMT works to repair the DNA of cancer cells that are damaged by treatment If a tumor is found to be unmethylated it means there is more MGMT present in the tumor than one that is methylated
Methylation of MGMT is believed to make tumor cells more responsive to drugs like temozolomide Studies have shown that temozolomide provides a very small improvement in outcome for many patients whose glioblastoma is MGMT-unmethylated
Patients with glioblastoma usually receive six weeks of radiation with a daily chemotherapy called temozolomide after their surgery followed by six to twelve months of additional temozolomide In this study only participants whose tumors are MGMT-methylated will receive temozolomide those participants whose tumors are MGMT-unmethylated will not receive temozolomide as studies have shown that temozolomide provides a very small improvement in outcome for many patients whose glioblastoma is MGMT-unmethylated
On this trial an initial cohort of participants Cohort 1 will receive the Personalized NeoAntigen Vaccine 5 priming doses and 2 booster doses over 20 weeks after having completed six weeks of standard radiation The study will examine the safety of the vaccine when given at several different time points and will examine the participant blood cells for signs that the vaccine induced an immune response
Three additional cohorts 1a 1b 1c were added to the study following completion of accrual to the original study cohort cohort 1 Each new cohort receives NeoVax and radiation therapy as administered to cohort 1 and will also receive pembrolizumab cohort 1a patients will start pembrolizumab win 2 weeks after start of RT and continue every 3 weeks for up to 2 years cohort 1b patients will start pembrolizumab 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years cohort 1c patients will receive a single dose of pembrolizumab administered within 2 weeks after start of RT re-start 2-4 weeks after completion of NeoVax priming and continue every 3 weeks for up to 2 years
The rationale for adding cohorts 1a 1b and 1c is 1 to assess the safety and feasibility of NeoVax when administered with pembrolizumab and 2 to determine if the timing of anti-PD-1 administration impacts the immunogenicity of NeoVax
An additional sub-study cohort 1d is being added for patients whose tumor is MGMT-methylated Cohort 1d will enroll patients with tumors for which the MGMT status is methylated or partially methylated patients on cohort 1d will receive standard daily temozolomide during radiation and as adjuvant therapy for up to six cycles following completion of radiation therapy The rationale for adding cohort 1d is to determine the safety and feasibility of NeoVax when administered with pembrolizumab and temozolomide
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 51986 | OTHER | Merck Co Inc | None |