Phase 1 Study of Personalized Cancer Vaccines with Poly-ICLC for Adults with Solid Tumors and Molecular Residual Disease

What this Trial Is About

Researchers are evaluating a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease in this phase 1 clinical trial. The study aims to assess the safety, feasibility, and immune response generated by synthetic long peptide personalized cancer vaccines combined with poly-ICLC. The hypothesis is that these vaccines will safely produce measurable neoantigen-specific T-cell responses that help clear circulating tumor DNA ctDNA. Participants receive personalized synthetic long peptide vaccines based on their cancer neoantigens, co-administered with poly-ICLC. Vaccinations occur on Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169, given intramuscularly by healthcare providers. The trial includes four cohorts with different cancer types muscle invasive bladder cancer, gastroesophageal adenocarcinoma, melanoma, and non-small cell lung cancer. During the study, participants undergo monitoring for safety by tracking adverse events from the first vaccine dose up to 30 days after the last dose, over approximately 13 months. Researchers also assess feasibility by measuring enrollment success, vaccine creation time, and delivery rates. Immune response is evaluated via ELISPOT analysis for up to 2 years after treatment, while molecular residual disease and recurrence-free survival are followed using ctDNA clearance and clinical assessments for up to about 66 months.

Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease