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

Status: Recruiting
Diagnosis: Lymphoma
NCT ID: NCT01953692 (View complete trial on
DFCI Protocol ID: 13-432


The purpose of this trial is to evaluate the safety, tolerability, and efficacy of pembrolizumab (MK-3475, KEYTRUDA®) in hematologic malignancies. The primary study hypotheses are that treatment with pembrolizumab will result in a clinically meaningful improvement in Objective Response Rate (ORR) or Complete Remission Rate (CRR).


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Philippe Armand, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David Avigan, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Kathleen McDermott,
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion criteria: - Has confirmed diagnosis of relapse or refractory Multiple Myeloma, Primary mediastinal Large B cell Lymphoma, non-Hodgkin lymphoma (NHL), Follicular Lymphoma, Diffuse Large B cell lymphoma, Hodgkin lymphoma or Myelodysplastic syndrome. - Has measureable disease - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale - Demonstrates adequate organ function - Prior therapy criteria must be met Exclusion Criteria: - Is currently participating in and receiving study therapy or has participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study therapy - Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years, has received a live vaccine within 30 days of planned start of study therapy, has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, received a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered from adverse events due to a previously administered agent - Has known clinically active central nervous system (CNS) involvement - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis - Has evidence of interstitial lung disease, active non-infectious pneumonitis, a known additional malignancy that is progressing or requires active treatment, an active infection requiring intravenous systemic therapy, an active autoimmune disease that has required systemic therapy, a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection - 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-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) - Has known symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
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