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

NCT07346196 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-07
Primary Completion
2031-08-22
Completion
2031-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346196 on ClinicalTrials.gov