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 tolerability of NeoSLP vaccines.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Personalized Synthetic Long Peptide Vaccine
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States
Quest Clinical Research
San Francisco, California, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
St. Louis Cancer Care
Bridgeton, Missouri, United States
To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12).
Progression-Free Survival at 12 months (PFS12) defined as time from first vaccine administration until disease progression by investigator assessment or death due to any cause.
Time frame: Until progression or death, assessed up to 12 months post first vaccine administration.
To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).
Time to Treatment Failure (TTF) is defined as time from first vaccine administration to discontinuation of treatment due to any reason, including disease progression, treatment toxicity, and death.
Time frame: Assessed up to 12 months post first vaccine administration
To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).
Overall Survival at 24 months (OS24) is the landmark of OS defined as the proportion of patients alive at 24 months.
Time frame: Until death, assessed up to 24 months post first vaccine administration
To assess the safety and tolerability of NeoSLP vaccines.
Adverse Events (AEs) and Severe Adverse Events (SAEs)
Time frame: Assessed up to 60 days from last vaccine administration
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Anna Gattani MD PC
New York, New York, United States