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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01953692
First Posted: October 1, 2013
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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).

Condition Intervention Phase
Myelodysplastic Syndrome Multiple Myeloma Hodgkin Lymphoma Non-Hodgkin Lymphoma Diffuse Large B-Cell Lymphoma Follicular Lymphoma Primary Mediastinal B-Cell Lymphoma Biological: Pembrolizumab Drug: Lenalidomide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 30 days after end of treatment for non-serious events and 90 days after end of treatment for serious events (up to 27 months) ]
  • Number of Participants Discontinuing Treatment due to an AE [ Time Frame: Up to end of treatment (up to 2 years) ]
  • Cohort 1: Objective Response Rate (ORR) Based on International Working Group (IWG) Criteria for MDS [ Time Frame: Up to end of treatment (up to 2 years) ]
  • Cohort 2: ORR based on International Myeloma Working Group (IMWG) criteria [ Time Frame: Up to end of treatment (up to 2 years) ]
  • Cohort 3: Complete Remission Rate (CRR) Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ]
  • Cohort 4: ORR Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ]
  • Cohort 5: ORR Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ]

Estimated Enrollment: 222
Actual Study Start Date: November 22, 2013
Estimated Study Completion Date: June 29, 2018
Estimated Primary Completion Date: October 11, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Myelodysplastic syndrome (MDS)
(Completed) 10 mg/kg by intravenous (IV) infusion every 2 weeks (Q2W). Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable adverse event(s) (AEs), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after Complete Response (CR) if treatment has been administered for 24 weeks and 2 doses have been administered after CR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Cohort 2: Relapse refractory/refractory multiple myeloma (MM)
Participants receive pembrolizumab 200 mg by IV infusion every 3 weeks (Q3W). Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after stringent complete response (sCR) if treatment has been administered for 24 weeks and 2 doses have been administered after sCR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Cohort 3: Relapsed/refractory (R/R) Hodgkin lymphoma (HL)
(Completed) 10 mg/kg by IV infusion Q2W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Cohort 4A: R/R mediastinal large B cell lymphoma (MLBCL)
Participants receive pembrolizumab 200 mg by IV infusion every 3 weeks (Q3W). Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Cohort 4B: R/R PD-L1-positive NHL
(Completed) Participants receive pembrolizumab 10 mg/kg by IV infusion Q2W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Cohort 4C: Relapsed/refractory Follicular Lymphoma (FL)
Participants receive pembrolizumab 200 mg by IV infusion Q3W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants receive pembrolizumab 200 mg by IV infusion Q3W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Cohort 5: R/R DLBCL combination treatment
Participants receive pembrolizumab 200 mg by IV infusion Q3W + lenalidomide 25 mg capsule by mouth (PO) or recommended Phase II dose for 21 consecutive days with 7 days off. Treatment with pembrolizumab + lenalidomide will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and they receive an additional 21 consecutive daily doses of lenalidomide + 2 doses of pembrolizumab after CR.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Lenalidomide
oral capsules
Other Name: REVLIMID®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953692


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01953692     History of Changes
Other Study ID Numbers: 3475-013
2013-001603-37 ( EudraCT Number )
First Submitted: September 26, 2013
First Posted: October 1, 2013
Last Update Posted: September 11, 2017
Last Verified: August 2017

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Lymphoma, Follicular
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Lenalidomide
Pembrolizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors