A Phase 1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line and CUE-101 Combination Therapy with Pembrolizumab in First Line Patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Associated ConditionsHead and Neck Cancer
Historically, patients with recurrent or metastatic head and neck cancer (HNSCC) have been treated with combinations of chemotherapeutic drugs. Recent studies with immunotherapy drugs that inhibit the programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) pathway, such as KEYTRUDA® (pembrolizumab), have demonstrated benefits for patients with metastatic HNSCC, however there remains a large unmet need for less toxic and more effective therapies. These treatment regimens provide some benefit in controlling the disease for a limited period of time but in almost all patients this treatment fails, and patients eventually die from their cancer. This clinical trial is being done to determine if therapy with a novel biologic drug (CUE-101) that activates the immune system to kill the cancer cells can be done safely and provide benefit that is better than currently available treatments. This research is being done to test the safety, tolerability and the effectiveness (how well the therapy works) of CUE-101 in patients with recurrent or metastatic HNSCC.