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Trial record 1 of 1 for:    NCT01953692 | Hodgkin Disease
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A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)

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.
 
ClinicalTrials.gov Identifier: NCT01953692
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 26, 2013
First Posted Date  ICMJE October 1, 2013
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE November 22, 2013
Actual Primary Completion Date June 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2016)
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 30 days after end of treatment (up to 25 months) ]
  • Number of Participants Discontinuing Treatment due to an AE [ Time Frame: Up to end of treatment (up to 2 years) ]
  • MDS: Overall Response Rate (ORR) Based on International Working Group (IWG) Criteria for MDS [ Time Frame: Up to Week 24 ]
  • SMM: ORR Based on International Myeloma Working Group (IMWG) Criteria [ Time Frame: Up to Week 24 ]
  • HL: Complete Remission Rate (CRR) Based on IWG Criteria for Lymphoma [ Time Frame: Up to Week 24 ]
  • NHL: ORR Based on IWG Criteria for Lymphoma [ Time Frame: Up to Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)
Official Title  ICMJE A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies
Brief Summary

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).

With Protocol Amendment 08, enrollment in the Multiple Myeloma arm (Cohort 2) has been completed and no further enrollment will be allowed and enrollment in the Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma arm (Cohort 5) has been discontinued and no further enrollment will be allowed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myelodysplastic Syndrome
  • Multiple Myeloma
  • Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Primary Mediastinal B-Cell Lymphoma
Intervention  ICMJE
  • Biological: Pembrolizumab
    IV infusion
    Other Names:
    • MK-3475
    • KEYTRUDA®
  • Drug: Lenalidomide
    oral capsules
    Other Name: REVLIMID®
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Pembrolizumab
  • Experimental: Cohort 2: Relapse refractory/refractory multiple myeloma (MM)
    (Completed) 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.
    Intervention: Biological: Pembrolizumab
  • 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.
    Intervention: Biological: Pembrolizumab
  • 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.
    Intervention: Biological: Pembrolizumab
  • 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.
    Intervention: Biological: Pembrolizumab
  • 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.
    Intervention: Biological: Pembrolizumab
  • 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.
    Intervention: Biological: Pembrolizumab
  • Experimental: Cohort 5: R/R DLBCL combination treatment
    (Discontinued) 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.
    Interventions:
    • Biological: Pembrolizumab
    • Drug: Lenalidomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
207
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2013)
100
Actual Study Completion Date  ICMJE June 26, 2020
Actual Primary Completion Date June 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Has confirmed diagnosis of relapse or refractory Multiple Myeloma (enrollment completed), Primary mediastinal Large B cell Lymphoma, non-Hodgkin lymphoma (NHL), Follicular Lymphoma, Diffuse Large B cell lymphoma (enrollment discontinued), Hodgkin lymphoma or Myelodysplastic syndrome (enrollment completed).
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Canada,   France,   Italy,   United States
 
Administrative Information
NCT Number  ICMJE NCT01953692
Other Study ID Numbers  ICMJE 3475-013
2013-001603-37 ( EudraCT Number )
MK-3475-013 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP