A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)
Mayo Clinic
Summary
This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.
Description
PRIMARY OBJECTIVE: I. To evaluate the safety of personalized neoantigen peptide vaccine in combination with pembrolizumab in advanced solid cancers. (Phase I and Pilot Cohort 5) II. To evaluate and estimate 24-months event-free survival (EFS) rate per Kaplan-Meier method in triple-negative breast cancer (TNBC) patients with residual cancer burden-2 and 3 (RCB-2 and RCB-3) after neoadjuvant pembrolizumab-based chemotherapy treated with neoantigen vaccine in combination with pembrolizumab. (Phase II Cohort 3) III. To evaluate and estimate 24-months event-free survival (DFS) rate per Kaplan-Meie…
Eligibility
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling. PHASE I PRE-REGISTRATION, ALL: * Willing to provide tissue specimens per protocol, or have clinically collected formalin-fixed paraffin-embedded (FFPE) tissue blocks, or available sequencing data available from commercial or research tests * NOTE 1: Includes fresh tissue specimen at pre-registration, or with or clinically collected FFPE tissue blocks for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo IRB protocols and neoantigen has been identified or REAL Neo vaccine produ…
Interventions
- DrugCyclophosphamide
Given IV
- BiologicalNeoantigen Peptide Vaccine
Receive personalized neoantigen vaccine SC
- BiologicalPembrolizumab
Given IV
- BiologicalSargramostim
Given SC
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBiopsy
Undergo tissue biopsy
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Location
- Mayo Clinic in FloridaJacksonville, Florida