Study on Pulsed Dose Chemotherapy and Pembrolizumab for Recurrent or Metastatic Head and Neck Cancer

Sponsor: Dan Zandberg

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06052839

Provider View

This clinical trial is testing a new way to give chemotherapy and the immunotherapy drug pembrolizumab to see if it can improve treatment outcomes for patients with recurrent or metastatic head and neck cancer.

Patient Parameters

Program Overview

The study aims to find out if a new sequence of giving chemotherapy and pembrolizumab can better control head and neck cancer that has come back or spread. Researchers believe that the current way of giving these treatments might suppress the immune system too much. By starting with pembrolizumab and giving chemotherapy less often, they hope to improve the effectiveness of the treatment.

Description

This trial is exploring a new way to give chemotherapy and pembrolizumab, a type of immunotherapy, to patients with recurrent or metastatic head and neck cancer. The goal is to see if this new method can improve treatment results and be easier for patients to tolerate. The study will start with pembrolizumab, followed by chemotherapy with carboplatin and paclitaxel, given less frequently. After completing four cycles of chemotherapy, patients will continue with pembrolizumab alone for up to two years. This approach is based on the idea that chemotherapy might work better after pembrolizumab and that giving it less often could reduce side effects. The study will also look at whether this method could be useful for other types of solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or metastatic squamous cell carcinoma of the head and neck that cannot be cured with local treatments.
  • Have a PD-L1 Combined Positive Score (CPS) greater than 1.
  • Be over 18 years old.
  • Have a performance status score of 0 to 2, meaning fully active or able to do light work.
  • Have measurable disease based on specific criteria.
  • Have normal organ and bone marrow function, including:
    • Neutrophil count of at least 1,000/mcL.
    • Platelet count of at least 100,000/mcL.
    • Total bilirubin within 1.5 times the normal limit.
    • Liver enzymes (AST/ALT) within 2.5 times the normal limit, or 5 times if there is liver involvement.
    • Creatinine clearance of at least 40 mL/min/1.73 m2.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 60 days after the last dose.
  • Men must agree to use contraception during the study and for 60 days after the last dose.
  • Be able to understand and sign a consent form.
  • If there are previous brain metastases, they must not be active or growing.

Exclusion Criteria

  • Have had prior systemic therapy for recurrent or metastatic disease, unless it was completed more than 6 months ago as part of curative treatment.
  • Have received prior anti-PD-1 or anti-PD-L1 therapy for recurrent/metastatic disease, unless it was part of curative treatment over a year ago.
  • Have squamous cell carcinoma of the skin or salivary gland origin.
  • Have an active autoimmune disease needing treatment in the past 3 months, except for certain conditions like vitiligo or psoriasis not needing systemic therapy.
  • Have a history of lung inflammation needing steroids or current lung disease.
  • Have had another cancer in the past 2 years that could affect the study results.
  • Have severe nerve damage.
  • Have any condition or treatment that could interfere with the study.
  • Have allergies to the study drugs.
  • Have a low neutrophil count below 1,500 cells/mm.

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