drugset
drugset / Trial / NCT05269381

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

NCT05269381 ↗

Phase 1/2 Recruiting 132 enrolled Mayo Clinic
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-03-31
Primary completion
2028-03-31
Completion
2028-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Neoantigen Peptide Vaccine Vaccine — Subcutaneous
Subject Pembrolizumab Monoclonal antibody — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background sargramostim Protein / enzyme biologic — Subcutaneous

Indications

breast adenocarcinoma carcinosarcoma of the corpus uteri cervical carcinoma cutaneous melanoma cutaneous neuroendocrine carcinoma endometrial cancer female breast carcinoma gastric adenocarcinoma gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma hepatocellular carcinoma high grade malignant neoplasm metastatic malignant neoplasm metastatic melanoma non-small cell lung carcinoma renal cell carcinoma skin squamous cell carcinoma triple-negative breast carcinoma urothelial carcinoma