NCT07346196

A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

A Randomized Phase II Trial of Induction Cemiplimab Plus Chemotherapy With or Without Fianlimab in Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer.

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	350 mg via IV
DRUG	Fianlimab	1600 mg via IV
DRUG	Carboplatin	Target AUC 5 via IV
DRUG	Paclitaxel	100 mg/m2 via IV
RADIATION	Radiation	Radiotherapy will be delivered to a total dose of 70 Gy.

Timeline

• Start date: 2027-02-07
• Primary completion: 2031-08-22
• Completion: 2031-08-22
• First posted: 2026-01-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study