Jaime Leandro Foundation for Therapeutic Cancer Vaccines
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
This is a Simon-two stage multi-cohort study to assess the safety and efficacy of neoantigen synthetic long peptide vaccines in patients with local or metastatic solid tumors. 1. To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12). 2. To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF). 3. To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24). 4. To investigate the immunogenicity of NeoSLP vaccines by ELISpot assay. 5. To assess the safety and to…
Patients must satisfy the following criteria to be enrolled in the protocol: Main Inclusion Criterion: Pancreatic 1. Patients who have local or metastatic pancreatic adenocarcinoma and have started first line therapy of Folfirinox (physician's choice for any concomitant therapies) 2. Patients who have undergone somatic tumor sequencing should consider FDA-approved pan-solid tumor therapies if they harbor an FDA-approved somatic alteration. For example, Entrectinib or Larotrectinib (if NTRK gene fusion- positive), Selpercatinib (if RET gene fusion-positive), Pembrolizumab (if MSI-H, dMMR, or…
Personalized Synthetic Long Peptide Vaccine