NCT03721757

CA209-891: Neoadjuvant and Adjuvant Nivolumab as Immune Checkpoint Inhibition in Oral Cavity Cancer

NICO - CA209-891: Neoadjuvant and Adjuvant Nivolumab as Immune Checkpoint Inhibition in Oral Cavity Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is to investigate the use of nivolumab in sequence with standard of care surgery and radiation/chemoradiation in locally advanced oral cavity Squamous cell carcinoma of the oral cavity.

Detailed description

Squamous cell carcinoma of the oral cavity is usually treated with surgery, often followed by radiation therapy with or without chemotherapy. Unfortunately despite this treatment, it recurs or spreads in about half of patients. In this trial the investigators aim to investigate the use of nivolumab in sequence with standard of care surgery and radiation/chemoradiation. Following confirmation of eligibility patients will be treated with a single dose of nivolumab 1-2 weeks prior to surgery to remove their tumour. Based on pathological risk factors determined following surgery, patients will be assigned to undergo adjuvant radiotherapy or chemoradiotherapy. Patients with high risk criteria (Extra capsular spread, involved margins) will be assigned to chemoradiotherapy. A further single dose of nivolumab will be given between surgery and commencement of radiotherapy or chemoradiotherapy. Following completion of chemo/radiation, patients will commence adjuvant nivolumab, with a total of 6 doses given at 4 weekly intervals. Patients will be followed up for 12 months post surgery. The primary objectives of this trial is to determine disease free survival at 12 months post surgery and the feasibility of recruiting to both cohorts.

Conditions

• Squamous Cell Carcinoma of the Oral Cavity

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab, Surgery, Radiotherapy	A single dose of nivolumab 7-14 days before curative surgery. A further single dose will be administered following surgery and prior to radiotherapy commencing. Six further doses of nivolumab will be received post radiotherapy
BIOLOGICAL	Nivolumab, Surgery, Chemoradiotherapy	A single dose of nivolumab 7-14 days before curative surgery. A further single dose will be administered following surgery and prior to Chemoradiotherapy (cisplatin) commencing. Six further doses of nivolumab will be received post radiotherapy

Timeline

• Start date: 2019-05-10
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2018-10-26
• Last updated: 2025-02-25

Locations

1 site across 1 country: United Kingdom