Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS

• Status: Not yet recruiting
• Trial end date: 2027-07-01

Summary

Background:

Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide. These cancers can have different causes. Human papilloma virus (HPV) is a virus that can infect the lining of a person s mouth, nose, and throat. When HPV infection leads to cancer, the outcomes tend to be good. But when HNSCC occurs in people who are not infected with HPV, the cancers are more likely to return after treatment; when this happens, overall survival is only about 10 months. Better treatments are needed.

Objective:

To test 2 drugs (valemetostat and pembrolizumab) in people with HNSCC that is not related to HPV infection.

Eligibility:

People aged 18 years and older with HPV-negative HNSCC or squamous non-small cell lung cancer (NSCLC).

Design:

Participants will be screened. They will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have imaging scans. They may have a biopsy: A small sample of tissue will be removed from the tumor.

Treatment will be given in 21-day cycles.

Pembrolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will receive pembrolizumab on the first day of each cycle.

Valemetostat is a tablet taken by mouth. Participants will take the tablet once a day at home. They will record the date and time of each dose in a diary. They will also write down any adverse effects they experience.

Participants may remain in the study up to 2 years.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Pembrolizumab