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A Phase I / II Study of Concurrent Cetuximab and Nivolumab in Patients with Recurrent and / or Metastatic Head and Neck Squamous Cell Carcinoma

Status
Active
Cancer Type
Head and Neck Cancer
Oral Cancer
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03370276
Protocol IDs
MCC-19178 (primary)
NCI-2017-02373
Study Sponsor
Moffitt Cancer Center

Summary

This phase I / II trial studies the side effects and how well cetuximab and nivolumab work in treating patients with oral cavity, oropharyngeal, paranasal sinus, hypopharyngeal, or laryngeal cancer that have come back or spread to other places in the body. Monoclonal antibodies, such as cetuximab and nivolumab, may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). (Phase I)
II. To determine the 1-year overall survival rate of concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic HNSCC. (Phase II)

SECONDARY OBJECTIVES:
I. To estimate response rate of patients treated with concurrent cetuximab and nivolumab who have recurrent and/or metastatic HNSCC. (Phase II)
II. To estimate progression-free survival of patients treated with concurrent cetuximab and nivolumab who have recurrent and/or metastatic HNSCC. (Phase II)
III. To evaluate the toxicity of the cetuximab and nivolumab combination in this patient population. (Phase II)

TERTIARY OBJECTIVES:
I. To identify potential biomarkers related to response to concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic HNSCC.

OUTLINE:
Patients receive cetuximab intravenously (IV) and nivolumab IV on day 1 of course 1 and every 2 weeks of subsequent courses. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.
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