Study on Pembrolizumab and Valemetostat for Treating Certain Head and Neck Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05879484

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and valemetostat, to see if they can effectively treat head and neck cancers that are positive for PD-L1 and negative for HPV. The study aims to find the best dose and evaluate the safety and effectiveness of this treatment.

Patient Parameters

Program Overview

Head and neck squamous cell carcinoma (HNSCC) is a common type of cancer worldwide. It can be caused by smoking, tobacco, or HPV infection. When these cancers occur in people without HPV, they are more likely to return after treatment, and survival rates are low. This study is testing a combination of two drugs, valemetostat and pembrolizumab, to see if they can improve treatment outcomes for these patients. The first part of the study will determine the best dose and safety of the drug combination, while the second part will focus on how well the treatment works in patients with HPV-negative HNSCC.

Description

This study is exploring a new treatment for head and neck squamous cell carcinoma (HNSCC), a common cancer worldwide. The study focuses on patients whose cancer is not caused by HPV, as these cases often have a poorer prognosis. The treatment involves two drugs: pembrolizumab, which is given through an IV, and valemetostat, which is taken as a tablet. The study is divided into two phases. The first phase will determine the best dose and safety of the drug combination, including patients with both HPV-positive and HPV-negative HNSCC, as well as certain lung cancers. The second phase will focus on the effectiveness of the treatment in patients with HPV-negative HNSCC. Participants will receive treatment in 21-day cycles and may continue in the study for up to two years. They will be closely monitored through regular exams, blood tests, and imaging scans to assess their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a diagnosis of HPV-negative head and neck squamous cell carcinoma (HNSCC) or certain other related cancers.
  • Must be 18 years or older.
  • Must have adequate organ and bone marrow function.
  • Must have a PD-L1 combined positive score (CPS) of 1 or higher.
  • Must not have received prior treatment with pembrolizumab or similar drugs for the second phase of the study.
  • Must have measurable disease according to specific criteria.
  • Must agree to use effective contraception during the study and for a period after the last dose of the study drugs.
  • Must be willing to undergo biopsies if required.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • History of allergic reactions to similar drugs used in the study.
  • Recent major surgery or radiation therapy.
  • Recent treatment with certain other cancer therapies.
  • History of treatment with EZH2 inhibitors.
  • Currently taking certain medications that affect drug metabolism.
  • Active use of immunosuppressive treatments.
  • Certain heart conditions or recent heart-related procedures.
  • History of autoimmune diseases, except for certain controlled conditions.
  • Recent active infections requiring treatment.
  • Pregnancy or breastfeeding.
  • Any other condition that would interfere with the study.

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