NCT03370276

Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.

Detailed description

PHASE I: Participants will be enrolled sequentially and treated at Dose Level 1, or Dose Level -1, every 2 weeks for 12 cycles or until discontinuation. Each cycle is 4 weeks. Cetuximab is given alone in lead-in period at Day -14 before Cycle 1 only. In all subsequent doses starting Cycle 1 Day 1, nivolumab and cetuximab will be given concurrently. Dose limiting toxicity (DLT) assessment will be performed during Cycle 1 and will start with the initiation of the combination of cetuximab and nivolumab (4 weeks). PHASE II: Once the maximum tolerated dose (MTD) or the recommended phase II dose of cetuximab is determined in Phase I, accrual to the phase II will begin. FOLLOW-UP: Participants will be followed for 2 years from End of Treatment. The imaging studies will be performed every 8 weeks (2 cycles) of the treatments during Cycle 1-6 and then every 12 weeks during Cycle 7-12 as per standard of care. Patient will be followed by treating physicians as per standard of care.

Conditions

• Squamous Cell Carcinoma of the Oropharynx
• Squamous Cell Carcinoma of the Larynx
• Squamous Cell Carcinoma of the Oral Cavity
• Squamous Cell Carcinoma of the Hypopharynx
• Squamous Cell Carcinoma of the Paranasal Sinus
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Cancer
• Head and Neck Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms.
DRUG	Cetuximab	Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.

Timeline

• Start date: 2017-12-20
• Primary completion: 2021-09-04
• Completion: 2023-12-23
• First posted: 2017-12-12
• Last updated: 2026-04-02
• Results posted: 2022-12-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study