Study of Personalized Neoantigen Peptide Vaccine with Pembrolizumab for Advanced Solid Tumors Phase III Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effects of a personalized neoantigen peptide-based vaccine, alone and combined with pembrolizumab, in patients with advanced solid tumors that have spread in the body. This phase III trial focuses on advanced cancers including triple-negative breast cancer and non-small cell lung cancer, aiming to understand the vaccines safety, immune response, and survival outcomes. The trial is sponsored by Mayo Clinic and includes multiple patient cohorts with specific cancer types and stages. Participants receive individualized neoantigen vaccines with sargramostim GM-CSF subcutaneously and pembrolizumab intravenously in several treatment cycles. Some cohorts also receive pre-treatment cyclophosphamide intravenously. Treatment cycles typically repeat every 21 days and continue up to two years unless disease progression or unacceptable side effects occur. Patients undergo tumor biopsies, blood sample collections, and imaging scans such as CT or MRI during the study. Throughout the trial, participants have regular assessments including safety evaluations, immune response measurements, and imaging to monitor disease status. After treatment ends, follow-up visits occur at 30 days and then every three months for up to two years. The study measures adverse events, event-free survival, disease-free survival, and immune response rates to understand the vaccines impact and safety profile.

Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors