NCT03162731

Nivolumab, Ipilimumab, and Radiation Therapy in Treating Patients With Stage III-IVB Head and Neck Cancer

A Pilot Trial of Nivolumab and Ipilimumab in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Cancer; CA209-931

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the side effects of nivolumab, ipilimumab and radiation therapy in treating patients with stage IVA-B head and neck cancer. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with stage IVA-B head and neck cancer.

Detailed description

PRIMARY OBJECTIVES: I. To investigate the safety of the combination of nivolumab and ipilimumab with radiation treatment for definitive management of patients with locally advanced squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. To estimate the 1 year progression-free survival (PFS) in all patients treated. II. To assess the overall response rate and overall survival of patients at one year TERTIARY OBJECTIVES: I. To explore whether PDL1 expression is associated with treatment response. II. To explore whether there is a net change in the Th1/Th2 ratio (IFN-gamma, IL-4, IL10, etc) or cell subset frequencies (M2 monocytes, myeloid-derived suppressor cells, etc) within a patient's peripheral blood either at baseline or in response to treatment is associated with treatment response. III. To explore whether exosomes or other immune related serum biomarkers change after combination therapy.

Conditions

• Larynx
• Lip, Oral Cavity and Pharynx

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV
BIOLOGICAL	Ipilimumab	Given IV
RADIATION	Simultaneous-Integrated Boost Intensity-Modulated Radiation Therapy	Undergo simultaneous integrated boost integrated modulated radiation therapy
RADIATION	Volume Modulated Arc Therapy	Undergo volumetric modulated arc therapy

Timeline

• Start date: 2017-05-11
• Primary completion: 2020-09-27
• Completion: 2022-11-16
• First posted: 2017-05-22
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study