CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer

This phase I/II trial studies the best dose and side effects of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax) and nivolumab and to see how well they work in treating patients with non-small cell lung cancer or squamous head and neck cancer that has spread to other places in the body. Vaccine therapy, such as CIMAvax vaccine may help slow down and stop tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab and 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 CIMAvax vaccine together with nivolumab or pembrolizumab may work better in treating patients with non-small cell lung cancer or squamous head and neck cancer.

NCT Number	NCT02955290
Lead Sponsor	Roswell Park Cancer Institute
Conditions	Advanced Head and Neck Squamous Cell Carcinoma, Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, PD-L1 Positive, Recurrent Head and Neck Squamous Cell Carcinoma, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8 +8 more
Enrollment	51 participants
Start Date	2016-12-22
Primary Completion	2026-11-25 (estimated)
Study Completion	2027-12-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-10