A Trial Assessing the Effect of Pembrolizumab Combined with Radiotherapy in Patients with Relapsed, Refractory, Specified Stages of Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides (MF)/Sezary Syndrome (SS)

Exclusion Criteria

• •Received chemotherapy or targeted small molecule therapy within 4 weeks prior to study entry or has not recovered from adverse events due to agents administered \>4 weeks earlier (except patients with ≤ grade 2 neuropathy)
• •Is currently or has participated in an IMP or device study within 4 weeks prior to the first dose of pembrolizumab
• •Received any other monoclonal antibody within 15 weeks prior to the first dose of pembrolizumab or has not recovered (≤ grade 1 or to baseline level) from adverse events due to agents administered \>4 weeks earlier. The exception to this is alemtuzumab which should not have been administered in the previous 12 weeks
• •Additional malignancy that is progressing or requires active treatment
• •Patients with known central nervous system (CNS) involvement with lymphoma
• •Hypersensitivity to pembrolizumab or its excipients
• •Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Stable use of corticosteroids (at a dose no higher than 10mg prednisolone per day over the preceding 4 weeks) is allowed
• •Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy
• •Current or prior use of immunosuppressive therapy within 7 days prior to start of treatment except the following: intranasal, inhaled, topical steroids or local steroid injections (eg. Intra-articular injection); systemic corticosteroids at physiologic doses (10mg/day or less of prednisolone or equivalent)
• •Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 therapy
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
• •Has known history of, or any evidence of active, non-infectious pneumonitis
• •History of other pulmonary disease such as interstitial lung disease, emphysema or chronic obstructive pulmonary disease
• •Is pregnant or breastfeeding
• •Has a known history of active TB
• •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with the subject's participation for the full duration of the trial or to participate in the trial is not in the patient's best interest, in the opinion of the treating investigator
• •Has known psychiatric or substance abuse disorders that would interfere with the requirements of the trial
• •Has a known history of HIV
• •Has known active Hepatitis B or Hepatitis C
• •Has received a live vaccine within 30 days prior to the planned start of study medication
• •Patients who have previously received a solid organ transplant
• •Patients who have previously received any allogeneic transplantation