Cemiplimab + Fianlimab for Head and Neck Cancer

CT
AR
Overseen ByAri Rosenberg
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Aa

Ari arirosenberg@bsd.uchicago.edu

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Adults with advanced HPV-positive head and neck cancer who haven't had treatment yet. They should have a specific stage of tumor growth, no prior radiation or chemo for this cancer, and measurable disease. Surgery is okay if there's still some disease left. Participants need to be over 18 with good performance status and organ function.

Inclusion Criteria

My throat cancer's HPV status was checked with a p16 test.
I have a tumor that can be measured with scans.
My cancer is at an advanced stage but has not spread widely.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive Cemiplimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles

9 weeks

Chemoradiation

Participants undergo chemoradiation with Cisplatin and Radiotherapy

7 weeks

Maintenance Treatment

Cemiplimab is administered for an additional 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cemiplimab
  • Fianlimab

Trial Overview

The trial tests if adding fianlimab to cemiplimab improves outcomes compared to just cemiplimab in treating head and neck cancer. It involves patients receiving radiation, carboplatin, paclitaxel along with the study drugs.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cemiplimab + chemo + fianlimabExperimental Treatment5 Interventions
Group II: Cemiplimab + chemoExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+