neoantigen peptide vaccine / Mayo Clinic, National Cancer Institute - LARVOL DELTA

A phase I pilot study of personalized neoantigen peptide-based vaccine in combination with pembrolizumab in advanced solid tumors (PNeoVCA). (ASCO 2024) - P1 | "Key eligibility criteria include 1) histologically confirmed locally advanced or metastatic solid malignancies and 2) cancer progression after at least one line of the standard-of-care (SOC) systemic treatment. For cohort 2, patients must be eligible to receive pembrolizumab per SOC or the treating physician's judgment."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Tumor-specific neoantigens • Oncology • Solid Tumor • CSF2

PNeoVCA: Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=132 | Recruiting | Sponsor: Mayo Clinic | N=36 ➔ 132 | Trial completion date: Feb 2026 ➔ Mar 2028 | Trial primary completion date: Feb 2025 ➔ Mar 2028

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Carcinosarcoma • Cervical Cancer • Cutaneous Melanoma • Endometrial Cancer • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • BRAF • ER • HER-2 • KRAS • NTRK • PGR • ROS1

PNeoVCA: Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: Mayo Clinic | Phase classification: P1 ➔ P1/2

Combination therapy • Metastases • Phase classification • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • ALK • BRAF • KRAS • MSI • NTRK • ROS1 • TMB

PNeoVCA: Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Feb 2024 ➔ Feb 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • ALK • BRAF • KRAS • MSI • NTRK • ROS1 • TMB

Pepscan's personalized neoantigen peptide pools in phase I trial "PneoVCA with Pembro in Advanced Solid Tumors" (PRNewswire) - "Pepscan...is excited to announce that it will supply personalized peptide pools for six patients in a phase I trial led by Mayo Clinic principal investigator Yanyan Lou, M.D., Ph.D., in collaboration with Keith L. Knutson, Ph.D. The trial tests the safety and tolerability of an experimental personalized peptide vaccine when given in combination with pembrolizumab in treating patients with a wide range of advanced solid tumors and tumors that have spread to other places in the body (metastases). The vaccine is designed to target certain proteins (neoantigens) on individuals' tumor cells. Combination immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and thereby interfere with the ability of the tumor cells to grow and spread."

Trial status • Breast Cancer • Gastric Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor