Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03417882
Status:
TERMINATED
Last Update Posted:
2023-08-08
First Post:
2017-11-14
Brief Title:
GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1 NSCLC
Sponsor:
BrightPath Biotherapeutics
Organization:
BrightPath Biotherapeutics
Study Overview
Official Title:
A Pilot Open-Label Multi-Center Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects With Non-Small Cell Lung Cancer With High PD-L1 Expression
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment rate too slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized Phase 2 2-stage open-label multi-center study of GRN-1201sargramostim pembrolizumab in subjects with PD-L1 metastatic NSCLC All subjects will have newly diagnosed metastatic PD-L1 TPS 50 NSCLC with no epidermal growth factor receptor EGFR or anaplastic lymphoma kinase ALK genomic tumor aberrations Subjects with EGFR or ALK genomic tumor aberrations with progression on FDA-approved therapy for these aberrations are eligible
Detailed Description:
This is a non-randomized Phase 2 2-stage open-label multi-center study of GRN-1201sargramostim pembrolizumab in subjects with metastatic PD-L1 NSCLC
All subjects will have newly diagnosed metastatic PD-L1 TPS 50 NSCLC with no epidermal growth factor receptor EGFR or anaplastic lymphoma kinase ALK genomic tumor aberrations
The study will follow a Simon two-stage design with up to 64 total subjects enrolled All subjects will receive GRN-1201 at 30 mg in combination with 75 µg sargramostim and 200 mg pembrolizumab
GRN-1201 is to be administered once weekly for 4 weeks followed by every 3-week dosing for an additional 12 doses 16 total doses of GRN-1201 Each dose of GRN-1201 will be given as 1 mL divided into 4 separate 025 mL intradermal injections on each day of treatment Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses
This study will consist of a screening period of up to 28 days a treatment period consisting of GRN-1201sargramostim administered weekly for 4 weeks 4 doses followed by administration every 3 weeks for 12 additional doses Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses
A follow up visit will occur approximately 4 weeks after the last administration of treatment for the study In addition all subjects will be followed for evaluation of disease progression and survival
All subjects will have newly diagnosed metastatic PD-L1 TPS 50 NSCLC with no epidermal growth factor receptor EGFR or anaplastic lymphoma kinase ALK genomic tumor aberrations
The study will follow a Simon two-stage design with up to 64 total subjects enrolled All subjects will receive GRN-1201 at 30 mg in combination with 75 µg sargramostim and 200 mg pembrolizumab
GRN-1201 is to be administered once weekly for 4 weeks followed by every 3-week dosing for an additional 12 doses 16 total doses of GRN-1201 Each dose of GRN-1201 will be given as 1 mL divided into 4 separate 025 mL intradermal injections on each day of treatment Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses
This study will consist of a screening period of up to 28 days a treatment period consisting of GRN-1201sargramostim administered weekly for 4 weeks 4 doses followed by administration every 3 weeks for 12 additional doses Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses
A follow up visit will occur approximately 4 weeks after the last administration of treatment for the study In addition all subjects will be followed for evaluation of disease progression and survival
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?:
None
Is an FDA AA801 Violation?:
None