iVAC-HNSCC01: Two-arm, placebo-controlled, double-blinded, randomized Phase II study to evaluate efficacy and safety of personalized multi-peptide vaccination in combination with Pembrolizumab in patients with unresectable recurrent, or metastatic head and neck squamous cell carcinoma

• Applicant: Professorin Dr. Juliane Walz
• Subject Area: Otolaryngology, Phoniatrics and Audiology ; Immunology
• Term: since 2026
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 569928171

Head and neck squamous cell carcinoma (HNSCC) is a frequent and devasting malignant disease. Most patients are diagnosed in advanced stage of disease. A later recurrence of the disease (relapse), after an initially successful therapy, is common. Immunotherapy with immune checkpoint inhibitors (ICI) has revolutionized cancer treatment and is now also approved for treatment of HNSCC patients with metastatic and unresectable recurrent disease. However, so far efficacy of ICI in HNSCC is limited with only approximately 20% of patients showing treatment response. Thus, novel combinatorial therapeutic options are urgently needed to improve specificity and efficacy of ICI in HNSCC patients. Targeted T cell-based immunotherapies comprising cancer vaccine, engage protein fragments, so called tumor associated HLA-presented Peptide antigens (TAA), to prime tumor specific T cells and have been suggested as low-side effect options to improve ICI treatment outcome. Our consortium has a longstanding experience in the development and clinical evaluation of personalized peptide vaccines based on premanufacture peptide warehouses comprising naturally presented, high frequent and immunogenic TAA that enable the fast and large-scale composition of individualized vaccine products for each patient. This project will evaluate the safety and efficacy of a personalized multi-peptide vaccination in combination with the ICI pembrolizumab an approved first-line therapy in patients with unresectable recurrent, or metastatic HNSCC within a two-armed, randomized, placebo-controlled, double-blinded Phase II clinical trial. Our warehouse-based personalized vaccination approach and in particular the combination with ICI might substantially impact treatment of HNSCC patients providing a novel immunotherapeutic approach that could increase survival without additional risk of harmful long-term damages.

• DFG Programme: Clinical Trials
• Co-Investigator: Dr. Sarah M. Schröder