Ignite Creation Date:
2024-05-06 @ 8:14 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02696356
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2016-02-03
Brief Title:
Phase 1 Study of GRN-1201 in HLA-A02 Subjects With Resected Melanoma
Sponsor:
BrightPath Biotherapeutics
Organization:
BrightPath Biotherapeutics
Study Overview
Official Title:
A Phase 1 Open-Label Multi-Center Multi-Dose Study of Intradermal GRN-1201 in HLA-A02 Subjects With Resected Stage IIb IIc or III Melanoma
Status:
COMPLETED
Status Verified Date:
2018-06
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 is a study of an investigational cancer vaccine called GRN-1201 Treatment with the GRN-1201 vaccine is a type of immunotherapy The goal of immunotherapy is to stimulate the bodys immune system white blood cells to attack cancer cells and kill them GRN-1201 consists of 4 different peptides small parts of proteins that are expressed by melanoma cells The intent of treatment with GRN-1201 is to increase your bodys immune response to melanoma
To further increase your bodys immune response against tumor cells the GRN-1201 vaccine will be mixed with Granulocyte-Macrophage Colony Stimulating Factor GM-CSF also known as sargramostim GM-CSF is a man-made protein that helps stimulate the immune system and increase the response against the tumor cells This is a phase I study which means that this will be the first time GRN-1201 is given in combination with GM-CSF to humans It will be tested in a small number of people to evaluate its safety find a safe dose and identify side effects The safety of GRN-1201 will be tested at three different doses the GM-CSF dose will remain the same
To further increase your bodys immune response against tumor cells the GRN-1201 vaccine will be mixed with Granulocyte-Macrophage Colony Stimulating Factor GM-CSF also known as sargramostim GM-CSF is a man-made protein that helps stimulate the immune system and increase the response against the tumor cells This is a phase I study which means that this will be the first time GRN-1201 is given in combination with GM-CSF to humans It will be tested in a small number of people to evaluate its safety find a safe dose and identify side effects The safety of GRN-1201 will be tested at three different doses the GM-CSF dose will remain the same
Detailed Description:
GRN-1201 is a novel HLA-A02-restricted multiple-peptide therapeutic cancer vaccine being developed by GreenPeptide for the treatment of melanoma because it can induce immune responses against tumor associated antigens TAAs particularly cytotoxic T cell CTL responses Granulocyte-macrophage-colony-stimulating-factor GM-CSF Leukine SanofiAventis will be administered in combination with GRN-1201 as an immuno-adjuvant
In contrast to advanced melanoma treatment options in the adjuvant setting are limited Surgical resection is the primary treatment of Stage IIb IIc and III melanoma patients The rate of disease recurrence in patients with American Joint Committee on Cancer AJCC TNM Stage II T2-4N0M0 and Stage III TanyNM0 disease ranges between 20 -60 with 5-year overall survival between 45 - 70 Thus safe and effective treatment options to reduce the risk of recurrence are much needed Considering their generally safe nature peptide-based cancer vaccines would be ideal to address this unmet medical need Patients with Stage IIb IIc or III melanoma are in general healthy following local therapy They are anticipated to maintain an immune system uncompromised by chemotherapy or disease burden Further they may have already developed immune response to TAAs targeted by GRN-1201 which may increase the probability of developing effective immune responses It is conceivable that the combination of peptide vaccines with an immune checkpoint inhibitor especially with a PD-1 pathway inhibitor could enhance the efficacy of immunotherapy without increasing toxicity Studies evaluating the combination of a melanoma vaccine with nivolumab in advanced melanoma 14 and resected high-risk metastatic melanoma patients 15 reported encouraging clinical outcome
The pre-clinical data suggest that GRN-1201 may have anti-tumor activity in the adjuvant setting or may enhance activity of other drugs such as checkpoint inhibitors in the adjuvant or metastatic disease setting by enhancing immune responses against TAAs
In contrast to advanced melanoma treatment options in the adjuvant setting are limited Surgical resection is the primary treatment of Stage IIb IIc and III melanoma patients The rate of disease recurrence in patients with American Joint Committee on Cancer AJCC TNM Stage II T2-4N0M0 and Stage III TanyNM0 disease ranges between 20 -60 with 5-year overall survival between 45 - 70 Thus safe and effective treatment options to reduce the risk of recurrence are much needed Considering their generally safe nature peptide-based cancer vaccines would be ideal to address this unmet medical need Patients with Stage IIb IIc or III melanoma are in general healthy following local therapy They are anticipated to maintain an immune system uncompromised by chemotherapy or disease burden Further they may have already developed immune response to TAAs targeted by GRN-1201 which may increase the probability of developing effective immune responses It is conceivable that the combination of peptide vaccines with an immune checkpoint inhibitor especially with a PD-1 pathway inhibitor could enhance the efficacy of immunotherapy without increasing toxicity Studies evaluating the combination of a melanoma vaccine with nivolumab in advanced melanoma 14 and resected high-risk metastatic melanoma patients 15 reported encouraging clinical outcome
The pre-clinical data suggest that GRN-1201 may have anti-tumor activity in the adjuvant setting or may enhance activity of other drugs such as checkpoint inhibitors in the adjuvant or metastatic disease setting by enhancing immune responses against TAAs
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