Clinical Trials /

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

NCT01953692

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Hodgkin Lymphoma
  • Mediastinal Large B-Cell Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Non-Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)
  • Official Title: A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 3475-013
  • SECONDARY ID: 2013-001603-37
  • SECONDARY ID: MK-3475-013
  • NCT ID: NCT01953692

Conditions

  • Myelodysplastic Syndrome
  • Multiple Myeloma
  • Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Primary Mediastinal B-Cell Lymphoma

Interventions

DrugSynonymsArms
PembrolizumabMK-3475, KEYTRUDA®Cohort 1: Myelodysplastic syndrome (MDS)
LenalidomideREVLIMID®Cohort 5: R/R DLBCL combination treatment

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). 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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1: Myelodysplastic syndrome (MDS)Experimental(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.
  • Pembrolizumab
Cohort 2: Relapse refractory/refractory multiple myeloma (MM)Experimental(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.
  • Pembrolizumab
Cohort 3: Relapsed/refractory (R/R) Hodgkin lymphoma (HL)Experimental(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.
  • Pembrolizumab
Cohort 4A: R/R mediastinal large B cell lymphoma (MLBCL)ExperimentalParticipants 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.
  • Pembrolizumab
Cohort 4B: R/R PD-L1-positive NHLExperimental(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.
  • Pembrolizumab
Cohort 4C: Relapsed/refractory Follicular Lymphoma (FL)ExperimentalParticipants 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.
  • Pembrolizumab
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)ExperimentalParticipants 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.
  • Pembrolizumab
Cohort 5: R/R DLBCL combination treatmentExperimental(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.
  • Pembrolizumab
  • Lenalidomide

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Merck Sharp & Dohme Corp.

Trial Keywords

  • PD1
  • PD-1
  • PDL1
  • PD-L1

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