NCT04298606

A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence

A Phase 0 Study of CIMAvax-EGF Vaccine in Patients Who Are at High Risk for Lung Cancer and Lung Cancer Survivors at Risk for Recurrence

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial studies the side effects of a vaccine called CIMAvax-EGF and to see how well it works in preventing lung cancer from developing in patients at high risk for lung cancer or coming back (recurrence) in stage IB-IIIA non-small cell lung cancer survivors. In many cancers such as lung cancer, there is a protein receptor called EGFR (epidermal growth factor receptor) that is overexpressed within these cancers. Activation of EGFR has shown to lead to tumor growth and development. Previous studies have indicated that EGFR activation is present in the airways of cancer-free subjects as well. CIMAvax-EGF vaccine works by causing the body to make antibodies against EGF that is being produced that could be possibly driving the risk for developing cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies. II. To access the molecular profile of blood, bronchial and nasal brushes, and bronchial biopsies to identify molecular markers associated with treatment and response. III. To establish the safety of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax-EGF) treatment in cancer-free individuals using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 5). SECONDARY OBJECTIVE: I. To evaluate quality of life score changes using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30) in patients who are at high risk for development of lung cancer or recurrence during CIMAvax-EGF treatment. OUTLINE: LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine intramuscularly (IM) at 0, 2, 4 and 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM once every 4 weeks (Q4W) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 60 days.

Conditions

• Chronic Obstructive Pulmonary Disease
• Lung Non-Small Cell Carcinoma
• Pneumonia
• Stage IB Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
BIOLOGICAL	Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine	Given IM

Timeline

• Start date: 2021-11-22
• Primary completion: 2025-12-05
• Completion: 2026-02-06
• First posted: 2020-03-06
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study