Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170)
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.
Treatment with pembrolizumab will continue for a maximum of 35 administrations
(approximately 2 years) or until documented disease progression by investigator assessment,
unacceptable adverse event(s) (AEs), intercurrent illness that prevents further
administration of treatment, participant withdraws consent, pregnancy of the participant,
noncompliance with study treatment or procedure requirements, or administrative reasons.
Are you eligible?
Diagnosis of relapsed or refractory primary mediastinal large B-cell lymphoma.
Previously exposed to rituximab as part of prior lines of treatment.
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
Radiographically measureable disease.
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
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.
Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigation al
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
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
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.