Study of Pembrolizumab and Local Chemotherapy for Sarcoma in the Arm or Leg

Inclusion Criteria

• Must be 12 years or older.
• Willing to provide written consent to participate.
• Agree to follow the treatment plan.
• Have a confirmed diagnosis of advanced or spreading sarcoma.
• Eligible for treatment with pembrolizumab.
• Suitable for isolated limb infusion (ILI) as determined by the doctor.
• Have tried at least one previous treatment or declined standard treatment options.
• Have measurable disease that can be tracked.
• Be in good general health with a performance status score of 2 or less.
• Have adequate organ function based on recent blood tests, including:
  • Hemoglobin of at least 8.0 g/dL
  • Neutrophil count of at least 1,000/mm³
  • Platelet count of at least 50,000/mm³
  • Normal liver and kidney function tests
  • Normal blood clotting times unless on blood thinners
• Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

• Have another cancer that needs treatment.
• Not suitable for ILI due to health conditions like heart disease.
• Allergic to pembrolizumab or its ingredients.
• Have uncontrolled illness or infection.
• Have active cancer spread to the brain unless stable and not needing steroids.
• Have significant immune system suppression.
• Have active or chronic infections like HIV, hepatitis B or C, or tuberculosis.
• Have a history of autoimmune diseases needing treatment in the past 2 years.
• Pregnant or breastfeeding women, or those planning to become pregnant.
• Men planning to father a child during the study or within 4 months after.
• Unwilling to use effective birth control during and after the study.
• Recently had other cancer treatments or surgery and not fully recovered.
• Participating in another clinical trial or using investigational drugs.
• Have psychiatric or substance abuse issues that affect participation.