A Phase II Study of Pembrolizumab (MK-3475) in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) or Relapsed or Refractory Richter Syndrome (rrRS)

In this study, participants with relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL) or relapsed or refractory Richter Syndrome (rrRS) will receive pembrolizumab (MK-3475). The efficacy of pembrolizumab in the treatment of rrPMBCL and rrRS will be evaluated.
Cancer (Oncology), Cancer (Oncology) - Lymphoma
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PMBCL:
  • Diagnosis of relapsed or refractory primary mediastinal large B-cell lymphoma.
  • Previously exposed to rituximab as part of prior lines of treatment.
  • RS:
  • Pathologic diagnosis per local institutional review of Richter syndrome that transformed from CLL.
  • Relapsed or refractory Richter syndrome and has received ≥1 previous treatment for RS.
  • All Participants:
  • Radiographically measureable disease.
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • Life expectancy >3 months.
  • Adequate organ function.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
  • Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
  • Is receiving systemic steroid therapy <3 days before the first dose of study drug or receiving any other form of immunosuppressive medication.
  • Known history of immunosuppression or receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Prior monoclonal antibody within 4 weeks prior to study Day 1.
  • Prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or prior radiation therapy within 4 weeks prior to study Day 1.
  • Allogeneic hematopoietic stem cell transplantation within the last 5 years.
  • Has a known additional malignancy (except underlying CLL for RS) that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Known clinically active central nervous system involvement.
  • Active autoimmune disease requiring systemic treatment in past 2 years.
  • History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
  • Active infection requiring intravenous systemic therapy.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study drug.
  • Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Known human immunodeficiency virus (HIV), or Hepatitis B or C.
  • Has received a live vaccine within 30 days prior to first dose of study drug.
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