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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01953692
First received: September 26, 2013
Last updated: July 15, 2016
Last verified: July 2016
  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's Lymphoma
Non-Hodgkin's 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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) ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Treatment due to an AE [ Time Frame: Up to end of treatment (up to 2 years) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • Cohort 2: ORR based on International Myeloma Working Group (IMWG) criteria [ Time Frame: Up to end of treatment (up to 2 years) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Cohort 4: ORR Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ] [ Designated as safety issue: No ]
  • Cohort 5: ORR Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: November 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953692

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, California
Call for Information (Investigational Site 0035) Recruiting
Duarte, California, United States, 91010
United States, Illinois
Call for Information (Investigational Site 0011) Recruiting
Chicago, Illinois, United States, 60637
Call for Information (Investigational Site 0039) Recruiting
Park Ridge, Illinois, United States, 60068
United States, Massachusetts
Call for Information (Investigational Site 0002) Recruiting
Boston, Massachusetts, United States, 02215
Call for Information (Investigational Site 0001) Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Call for Information (Investigational Site 0026) Recruiting
St. Louis, Missouri, United States, 63110
United States, New Jersey
Call for Information (Investigational Site 0008) Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Call for Information (Investigational Site 0006) Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Call for Information (Investigational Site 0034) Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Call for Information (Investigational Site 0031) Recruiting
Temple, Texas, United States, 76504
United States, Washington
Call for Information (Investigational Site 0012) Recruiting
Seattle, Washington, United States, 98109
United States, West Virginia
Call for Information (Investigational Site 0032) Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Call for Information (Investigational Site 0028) Recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Medical Information Centre Centre de l'information medicale de Merck Canada    514-428-8600 / 1-800-567-2594      
France
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01953692     History of Changes
Other Study ID Numbers: 3475-013  2013-001603-37 
Study First Received: September 26, 2013
Last Updated: July 15, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Pembrolizumab
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Hodgkin Disease
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
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on July 24, 2016