Last updated on January 2019

GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC


Brief description of study

This is a non-randomized, Phase 2, 2-cohort, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + pembrolizumab in subjects with PD-L1+ metastatic NSCLC. Both first and second line subjects will be enrolled including:

  • Cohort 1: Subjects with newly diagnosed, metastatic PD-L1+ (TPS 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or
  • Cohort 2: Subjects with metastatic PD-L1+ (TPS 1%) NSCLC with progression on or after first-line platinum-based regimen. Subjects with EGFR or ALK genomic tumor aberrations with progression on FDA-approved therapy for these aberrations are eligible

Detailed Study Description

This is a non-randomized, Phase 2, 2-cohort, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + pembrolizumab in subjects with metastatic PD-L1+ NSCLC.

Both first and second line subjects will be enrolled including:

  • Cohort 1: Subjects with newly diagnosed, metastatic PD-L1+ (TPS 50%) NSCLC with no EGFR or ALK genomic tumor aberrations, or
  • Cohort 2: Subjects with metastatic PD-L1+ (TPS 1%) NSCLC with progression on or after first-line platinum-based regimen. Subjects with EGFR or ALK genomic tumor aberrations with progression on FDA-approved therapy for these aberrations are eligible.

Each cohort will follow a Simon two-stage design [1] with up to 43 subjects in Cohort 1 and 47 subjects in Cohort 2 for a total of 90 subjects enrolled if both cohorts enroll both stages. All subjects will receive GRN-1201 at 3.0 mg in combination with 75 g 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.

Clinical Study Identifier: NCT03417882

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