Pembrolizumab In Hematologic Malignancies, Including Multiple Myeloma

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013)(KEYNOTE-013)

What is the purpose of this trial?

The purpose of this trial is to evaluate the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in hematologic malignancies (myelodysplastic syndrome [MDS], multiple myeloma [MM], Hodgkin's lymphoma [HL], mediastinal large B cell lymphoma [MLBCL], and non-Hodgkin's lymphoma [NHL]).Trial Overview

• Treatments: Pembrolizumab
• Enrollment: Approx. 106 patients will be enrolled in this study.
• Who Sponsors this trial? Merck Sharp & Dohme Corp.
• Phase 1
• Trial ID: MM-0511

• Have primary or secondary myelodysplastic syndrome (MDS) and have failed to respond to at least 4 cycles of hypomethylating agent, OR Have a confirmed diagnosis of relapsed/refractory multiple myeloma (R/R MM) that have failed at least two lines of prior therapy including bortezomib and an IMiD (thalidomide, pomalidomide, lenalidomide), OR Have relapsed/refractory nodular sclerosing or mixed cellularity Hodgkin lymphoma, relapsed/refractory mediastinal large B cell lymphoma, or any other relapsed/ refractory programmed cell death ligand 1 (PD-L1) positive non-Hodgkin lymphoma that have failed, are ineligible for, or refused a stem cell transplant. Hodgkin lymphoma participants must have relapsed after treatment with or failed to respond to brentuximab vedotin.
• Have measureable disease
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
• Demonstrate adequate organ function
• For MDS: Able to provide bone marrow biopsy/aspirate material for biomarker analysis or is willing to provide a newly obtained bone marrow biopsy/aspirate
• For multiple myeloma: Able to provide archival and newly obtained bone marrow aspirate/biopsy material for biomarker analysis
• For HL & NHL: Able to provide a lymph node biopsy for biomarker analysis (archival or newly obtained at screening); for participants with programmed cell death ligand 1 (PD-L1) positive NHL an archival or newly obtained lymph node biopsy may be used for study entry with additional biopsy at screening

• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
• Has a diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Has received a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered from adverse events due to agents administered more than 4 weeks earlier
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent
• Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years
• Has a known additional malignancy that is progressing or requires active treatment
• Has known clinically active central nervous system (CNS) involvement
• Has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
• Has evidence of interstitial lung disease
• Has an active infection requiring intravenous systemic therapy
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
• Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, anti-programmed cell death ligand 2 (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)
• Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection
• Has known symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• Has received a live vaccine within 30 days of planned start of study therapy
• For MDS only: Is currently receiving treatment with any colony stimulating factors and other hematopoetic cytokines within 2 weeks of enrollment into trial
• For MM only: Has myeloma and a history of repeated infections, primary amyloidosis, hyperviscosity, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), Waldenström's macroglobulinemia, or Immunoglobulin M (IgM) myeloma

For more information on this trial, click here or visit www.sparkcures.com.