drugset / Trial / NCT02955290

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

NCT02955290

Phase 1/2 Active not recruiting 51 enrolled Roswell Park Cancer Institute
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-12-22
Primary completion
2025-05-23
Completion
2027-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject CIMAvax-EGF Vaccine Intramuscular
Subject Nivolumab Monoclonal antibody Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous