NCT07514767

Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma

NOCANO: Nivolumab as Neoadjuvant Immunotherapy for Patients With Oral CANcer and Identification of Response-predictive Biomarkers in Tumour Draining Lymph NOdes

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Prof. Lars Olaf Cardell · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Identification of predictive molecular biomarkers of tumor response to treatment will also be performed.

Detailed description

Patients 18 years old and above, any gender, naïve to immunotherapy, and with histologically confirmed T2-4 N0-3 M0 resectable Oral Squamous Cell Carcinoma tumors will be eligible for this clinical trial. Enrolled patients must be fit and eligible for the primary treatment of curative surgery at the primary tumor site with sentinel node identification and removal. Total 60 patients fulfilling eligibility criteria will be included during the period of three years and will receive a total of 2 doses (240 mg per dose) of nivolumab at day 1 and day 15 prior to the curative standard of care surgery. After the study treatment and standard of care surgery, the study participants will be offered evidence-based adjuvant therapy, such as radiotherapy, chemoradiotherapy and checkpoint inhibitors or combination treatments, according to the existing evidence. The study duration per participant after inclusion is approximately 27 weeks including two study-related follow-up visits at 3 and 6 months after the second nivolumab dose. Survival status and disease status of every participant will be also reviewed in medical records at 1, 2, 3 and 5 years after the second nivolumab dose.

Conditions

• Oral Squamous Cell Carcinoma (OSCC)

Interventions

Type	Name	Description
DRUG	Nivolumab (240 mg)	Nivolumab at day 1 and day 15 prior to the curative standard of care surgery.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-09-01
• Completion: 2033-09-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Sweden