GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC
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|ClinicalTrials.gov Identifier: NCT03417882|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2018
Last Update Posted : June 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic NSCLC||Biological: GRN-1201 + Pembrolizumab||Phase 2|
This is a non-randomized, Phase 2, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + 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 3.0 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 0.25 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-1201/sargramostim 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study will follow a Simon two-stage design  with up to 64 subjects enrolled. All subjects will receive GRN-1201 at a dose of 3.0 mg per peptide in combination with 75 µg sargramostim (Leukine®) and 200 mg pembrolizumab.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 3, 2019|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Cohort 1
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.
Biological: GRN-1201 + Pembrolizumab
GRN-1201 will be administered in combination with Pembrolizumab
Other Name: Pembrolizumab
- Assess the effect, as measured by response rate of the addition of GRN-1201 to Pembrolizumab [ Time Frame: First dose through 16 weeks after last dose of study drug ]Tumor assessment over time using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Evaluate the adverse event profile for the combination of GRN-1201 and Pembrolizumab as assessed by treatment -related events according to CTCAE version 4 [ Time Frame: First dose through 16 weeks after last dose of study drug ]The safety and tolerability of GRN-1201/sargramostim + pembrolizumab will be evaluated by local and systemic signs and symptoms of injection site reactions, and incidence of adverse events including immune related adverse events (irAEs).
- Host immune response to GRN-1201 [ Time Frame: First dose through 16 weeks after last dose of study drug ]
Immune responses to GRN-1201 will be monitored to establish proof-of principle for the proposed pharmacological effect and demonstrate immunogenicity of GRN-1201.
Immune response to the individual peptides will be assessed by measurement of cytotoxic T lymphocytes (CTLs) (by gamma interferon [IFN-γ] ELISPOT assay) and by measurement of antibodies to each peptide
- Clinical Benefit response rate (CR + PR + SD >/= 16 weeks) [ Time Frame: First dose through 16 weeks after last dose of study drug ]Tumor assessment over time using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Progression-free survival [ Time Frame: First dose through 2 years after last dose of combination treatment ]Progression-free survival will be determined by tumor assessments or death from any cause
- Duration of response in responding subjects [ Time Frame: First dose through 16 weeks after last dose of study drug ]The duration of objective response will be assessed
- Duration of clinical benefit [ Time Frame: First dose through 16 weeks after last dose of study drug ]The duration of clinical benefit response rate will be assessed
- Overall survival [ Time Frame: First dose through 16 weeks after last dose of study drug ]All subjects will be followed for overall survival after discontinuation of combination treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417882
|United States, California|
|St Joseph Hospital of Orange|
|Orange, California, United States, 92868|
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Florida Hosptial Cancer Center- AdventHealth|
|Orlando, Florida, United States, 32804|
|United States, Illinois|
|Robert H Lurie Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Skokie, Illinois, United States, 60077|
|United States, Kentucky|
|Norton Healthcare Cancer Institute|
|Louisville, Kentucky, United States, 40202|
|United States, Louisiana|
|East Jefferson General Hospital|
|Metairie, Louisiana, United States, 70006|
|Ocshner Cancer Institute|
|New Orleans, Louisiana, United States, 70121|
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|United States, Virginia|
|Virginia Cancer Institute|
|Richmond, Virginia, United States, 23230|