Study on Pembrolizumab and Gemcitabine for Advanced Mycosis Fungoides or Sézary Syndrome

Inclusion Criteria

• Diagnosed with mycosis fungoides or Sézary syndrome at stage IB or higher, meaning the disease affects at least 10% of the skin.
• Aged 18 years or older.
• In good general health with an ECOG performance score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have received at least one previous systemic treatment for mycosis fungoides or Sézary syndrome.
• Stopped any previous systemic cancer treatment at least two weeks before starting the study treatment.
• May continue using low-dose steroids if needed to prevent worsening of the disease.
• Previous treatment with gemcitabine is allowed.
• Must meet specific laboratory test requirements (see Table 1 for details).
• Must provide written informed consent to participate in the trial.
• Women must not be pregnant or breastfeeding and must agree to use effective birth control if they are of childbearing potential.
• Men must agree to use contraception and avoid donating sperm during the study and for a specified period after the last dose of treatment.

Exclusion Criteria

• Women who test positive for pregnancy within 72 hours before starting treatment.
• Previous treatment with certain immune therapies, such as anti-PD-1 or anti-PD-L1 drugs.
• Have an immune deficiency or are taking high doses of steroids or other immune-suppressing drugs.
• Have an active infection that requires treatment.
• Have another cancer that is progressing or has needed treatment in the past year, except for certain skin cancers or in situ cancers that have been treated.
• Participating in another clinical trial or have used an investigational drug or device recently.
• Have not recovered from side effects of previous cancer treatments.
• Have received a live vaccine recently.
• Have an active autoimmune disease that required treatment in the past year.
• Have active central nervous system lymphoma unless stable and not needing steroids.
• Have severe allergies to pembrolizumab or its ingredients.
• Have a history of HIV, active hepatitis B or C, or tuberculosis.
• Have a history of lung disease that required steroids.
• Have had a tissue or organ transplant.
• Have any condition that might interfere with the study or is not in the best interest of the participant.
• Have psychiatric or substance abuse issues that would affect participation.
• Are pregnant, breastfeeding, or planning to have children during the study and for a specified period after treatment.