Phase II Study of Pembrolizumab and GVD for Treating Relapsed or Resistant Hodgkin Lymphoma

Inclusion Criteria

• Diagnosed with classical Hodgkin's lymphoma.
• The disease has returned or not responded to initial treatment, confirmed by a biopsy.
• Have had one previous multi-drug chemotherapy treatment.
• Willing and able to provide written consent to participate in the trial.
• Aged 18 years or older.
• Have measurable disease based on specific medical criteria.
• Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function, including:
  • Neutrophil count of at least 1000/mcL.
  • Platelet count of at least 50,000/mcL.
  • Hemoglobin level of at least 8 g/dL.
  • Normal kidney function or creatinine clearance of at least 60 mL/min.
  • Liver function within specified limits.
  • Lung function adequate for carbon monoxide diffusion.
  • Heart's ejection fraction of at least 45%.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception.
• Men must agree to use effective contraception.

Exclusion Criteria

• Have received more than one prior treatment for Hodgkin Lymphoma.
• Are pregnant or breastfeeding. Breastfeeding must be stopped before starting treatment.
• Have a medical condition unrelated to Hodgkin's Lymphoma that makes participation inappropriate.
• Have had radiotherapy within two weeks before starting the study treatment and have not fully recovered from its effects.
• Have active cancer spread to the brain or spinal cord.
• Have an active autoimmune disease requiring treatment in the past two years.
• Have active HIV, Hepatitis B, or Hepatitis C infections.
• Have received a live vaccine within 30 days before starting the study drug.
• Have a history of lung inflammation requiring steroids or current lung inflammation.
• Have an active infection needing treatment.
• Have had a solid organ transplant or a stem cell transplant within the last five years, unless symptom-free for more than five years.