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



Status:Recruiting
Conditions:Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/18/2017
Start Date:November 22, 2013
End Date:June 29, 2018
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies

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).


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
We found this trial at
12
sites
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New York, NY
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North Ryde, 2113
Phone: 61 2 8988 8428
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North Ryde,
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Park Ridge, IL
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Saint Louis, MO
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Seattle, WA
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Temple, TX
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