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 |
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).
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
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