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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 September 2014 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: September 25, 2014
Last verified: September 2014
  Purpose

The purpose of this trial is to evaluate the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in hematologic malignancies (myelodysplastic syndrome [MDS], multiple myeloma [MM], Hodgkin's lymphoma [HL], mediastinal large B cell lymphoma [MLBCL], and non-Hodgkin's lymphoma [NHL]).


Condition Intervention Phase
Myelodysplastic Syndrome
Multiple Myeloma
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Biological: Pembrolizumab
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 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 (up to 25 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 ]
  • MDS: Overall Response Rate (ORR) Based on International Working Group (IWG) Criteria for MDS [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
  • Relapsed/Refractory MM: ORR based on International Myeloma Working Group (IMWG) criteria [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
  • HL: Complete Remission Rate (CRR) Based on IWG Criteria for Lymphoma [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
  • MLBCL/PD-L1 positive NHL: ORR Based on IWG Criteria for Lymphoma [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDS
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), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, 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
Experimental: Relapsed/Refractory MM
10 mg/kg by IV infusion Q2W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, 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
Experimental: HL
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), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, 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
Experimental: MLBCL/PD-L1 positive NHL
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), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have primary or secondary myelodysplastic syndrome (MDS) and have failed to respond to at least 4 cycles of hypomethylating agent, OR Have a confirmed diagnosis of relapsed/refractory multiple myeloma (R/R MM) that have failed at least two lines of prior therapy including bortezomib and an IMiD (thalidomide, pomalidomide, lenalidomide), OR Have relapsed/refractory nodular sclerosing or mixed cellularity Hodgkin lymphoma, relapsed/refractory mediastinal large B cell lymphoma, or any other relapsed/ refractory programmed cell death ligand 1 (PD-L1) positive non-Hodgkin lymphoma that have failed, are ineligible for, or refused a stem cell transplant. Hodgkin lymphoma participants must have relapsed after treatment with or failed to respond to brentuximab vedotin.
  • Have measureable disease
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Demonstrate adequate organ function
  • For MDS: Able to provide bone marrow biopsy/aspirate material for biomarker analysis or is willing to provide a newly obtained bone marrow biopsy/aspirate
  • For MM, Able to provide archival and newly obtained bone marrow aspirate/biopsy material for biomarker analysis
  • For HL & NHL: Able to provide a lymph node biopsy for biomarker analysis (archival or newly obtained at screening); for participants with programmed cell death ligand 1 (PD-L1) positive NHL an archival or newly obtained lymph node biopsy may be used for study entry with additional biopsy at screening

Exclusion Criteria:

  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
  • Has a diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
  • Has received a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent
  • Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years
  • Has a known additional malignancy that is progressing or requires active treatment
  • Has known clinically active central nervous system (CNS) involvement
  • Has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  • Has evidence of interstitial lung disease
  • Has an active infection requiring intravenous systemic therapy
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • 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-PD-L1, anti-programmed cell death ligand 2 (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 a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection
  • Has known symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Has received a live vaccine within 30 days of planned start of study therapy
  • For MDS only: Is currently receiving treatment with any colony stimulating factors and other hematopoetic cytokines within 2 weeks of enrollment into trial
  • For MM only: Has myeloma and a history of repeated infections, primary amyloidosis, hyperviscosity, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), Waldenström's macroglobulinemia, or Immunoglobulin M (IgM) myeloma
  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, Maryland
Call for Information (Investigational Site 0007) Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Call for Information (Investigational Site 0001) Recruiting
Boston, Massachusetts, United States, 02215
Call for Information (Investigational Site 0002) Recruiting
Boston, Massachusetts, United States, 02215
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, Texas
Call for Information (Investigational Site 0003) Recruiting
Houston, Texas, United States, 77030-4009
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: Study Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

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: September 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Preleukemia
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Precancerous Conditions
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014