MedTrace Logo

A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment

NCT07179315 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-03-04

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 who have detectable minimal-residual disease after definitive treatment. The main question(s) it aims to answer are:

* Does combining cemiplimab with fianlimab provide better results in preventing cancer recurrence than cemiplimab alone?
* Is the combination treatment safe and well-tolerated by patients? Researchers will compare the group receiving cemiplimab alone to the group receiving the combination of cemiplimab and fianlimab to see if the combination leads to improved treatment outcomes, such as better disease control and longer survival.

Participants will:

* Receive either cemiplimab alone or a combination of cemiplimab and fianlimab.
* Attend regular follow-up visits for monitoring of treatment efficacy and side effects.
* Undergo assessments to measure disease progression and response to treatment.

Conditions

Interventions

DRUG

cemiplimab+fianlimab

Fianlimab 1600 mg + Cemiplimab 350 mg FDC

DRUG

Cemiplimab

350 mg

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Ari Rosenberg · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2029-11-30
Completion
2029-11-30
FDA Drug
Yes

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 NCT07179315 on ClinicalTrials.gov