NCT01935921

Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer

A Phase Ib Trial of Concurrent Cetuximab (ERBITUX®) and Intensity Modulated Radiotherapy (IMRT) With Ipilimumab (YERVOY®) in Locally Advanced Head and Neck Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial studies the side effects and best dose of ipilimumab when given together with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To identify the starting dose of ipilimumab, in combination with standard cetuximab-IMRT in patients with high- or intermediate-risk, locally advanced head and neck squamous cell carcinoma (HNSCC), for use in a future clinical efficacy trial. SECONDARY OBJECTIVES: I. To estimate the clinical response of patients with high- or intermediate-risk, locally advanced HNSCC treated with above regimen using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. II. To estimate the 2-year progression-free survival of patients with high- or intermediate-risk, locally advanced HNSCC treated with the above regimen. III. To investigate serum, lymphocyte and tissue biomarkers as predictors of progression-free survival, toxicity and other outcome parameters in patients with high- or intermediate-risk, locally advanced HNSCC treated with above regimen. IV. To estimate the association by dose-response modeling between dose of ipilimumab, clinical response and biomarkers. OUTLINE: This is a dose-escalation study of ipilimumab. Patients receive cetuximab intravenously (IV) over 60-120 minutes on days 1, 8, 15, and 22. Treatment with cetuximab repeats every 4 weeks for 2 courses. Beginning in week 2 of course 1, patients undergo concurrent IMRT 5 days per week for 7 weeks. Beginning in week 4 (day 1 of course 2) patients also receive ipilimumab IV over 90 minutes once every 21 days for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may undergo surgery after completion of therapy. After completion of study treatment, patients are followed up every 12 weeks for 1 year, every 6 months for 1 year, and then every 12 months for 3 years.

Conditions

• Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
• Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab	Given IV
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
BIOLOGICAL	Ipilimumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-04-09
• Primary completion: 2016-10-29
• Completion: 2018-07-06
• First posted: 2013-09-05
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States