Clinical Trials

The 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)

Protocol: OSU-15215

Full Title

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)

Purpose

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.

Study Objective

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?

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 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

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.

Non-Hodgkin’s Lymphoma (B- & T-Cell) Lymphoma