Pembrolizumab + Valemetostat for Head and Neck Cancer
Trial Summary
What is the purpose of this trial?
Background: Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide. These cancers have different causes, with smoking/tobacco exposure and human papilloma virus infection being the most common. . 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, thus better treatments are needed. Objective: To test a combination treatment using 2 drugs (valemetostat and pembrolizumab) in people with HNSCC. Phase 1b of the study will determine a recommended dose of the 2 drugs and evaluate how safe the combination is.; this will include patients with HPV-positive and HPV-negative HNSCC, as well as squamous cell NSCLC that have progressed on anti-PD-1/anti-PD-L1 therapies.Phase II will determine how effective the combination is and will focus on patients with HPV-negative HNSCC. Eligibility: People aged 18 years and older with HPV-negative HNSCC, sinonasal carcinoma of the head and neck, 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.
Research Team
Vassiliki Saloura, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults with HPV-negative head and neck squamous cell carcinoma, sinonasal cancer, or squamous non-small cell lung cancer. They must have good organ function, be able to undergo biopsies, not be pregnant or breastfeeding, agree to use contraception, and sign a consent form. Excluded are those with autoimmune diseases, prior malignancies within a certain period, uncontrolled infections or illnesses.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Pembrolizumab (PD-L1 Inhibitor)
- Valemetostat (Histone Methyltransferase Inhibitor)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School