Study on Nab-Paclitaxel and Nivolumab for Treating Recurrent or Metastatic Head and Neck Cancer After PD-1 or PD-L1 Inhibitor Treatment

Inclusion Criteria

• Diagnosed with recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC) in specific areas like the oral cavity, larynx, oropharynx, or neck.
• Known p16 status if cancer is in the oropharynx or neck.
• Have measurable cancer that can be tracked using scans or exams.
• Cancer must have progressed after treatment with a PD-1 or PD-L1 inhibitor.
• At least 18 years old.
• Good overall health with a performance status of less than 1.
• Normal blood and organ function, including:
  • Hemoglobin over 9 g/L
  • Neutrophil count of at least 1,500/mcl
  • Platelet count of at least 100,000/mcl
  • Total bilirubin of 1.5 mg/dL or less
  • AST/ALT levels within specified limits
  • Serum creatinine within specified limits
• Agree to use effective birth control during and for six months after the study.
• Able to understand and sign a consent form.

Exclusion Criteria

• History of another cancer unless treatment was completed over a year ago and there is no evidence of disease.
• Active cancer spread to the brain unless previously treated and stable.
• Severe allergic reactions to similar drugs used in the study.
• Taking high doses of steroids recently.
• Severe nerve damage.
• Serious uncontrolled illnesses like heart failure or infections.
• Pregnant or breastfeeding women.
• Previous organ or stem cell transplant.
• Active autoimmune diseases requiring recent treatment.
• Prisoners or those detained.
• Previous treatment with taxane drugs for recurrent or metastatic cancer.