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A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With AML

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02708641
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : July 13, 2018
Information provided by (Responsible Party):
Michael Boyiadzis, University of Pittsburgh

Brief Summary:
This is a phase II study to evaluate the effect of pembrolizumab on the duration of remission in acute myeloid leukemia. Pembrolizumab is given after complete remission is obtained in those with AML at least 60 years old who are not candidates for allogeneic stem cell transplant. The primary purpose of this study is determine if the time to relapse can be extended. Additionally, the safety and tolerability of pembrolizumab will be closely monitored.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With Acute Myeloid Leukemia (AML) Who Are Not Transplantation Candidates
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: AML patients
pembrolizumab 200 mg given IV once every three weeks
Drug: pembrolizumab
200 mg IV given every three weeks
Other Name: Keytruda

Primary Outcome Measures :
  1. Time to relapse of AML [ Time Frame: From first dose up to 48 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 48 months or end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • be willing and able to provide written informed consent for the trial
  • be ≥ 60 years of age on day of signing informed consent
  • have a newly diagnosed AML based on the World Health Organization (WHO) criteria, currently in first complete remission (CR) on a bone marrow biopsy performed within 4 weeks of treatment initiation
  • have received the last dose of induction or consolidation chemotherapy within 3 months of treatment initiation
  • not be eligible for or willing to proceed with allogeneic stem cell transplant or for whom allogeneic stem cell transplant is not considered standard of care
  • have a performance status of ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • demonstrate adequate organ function, with all screening labs performed within 10 days of treatment initiation
  • transfusion independent (no red blood cell or platelet transfusions in the preceding 2 weeks of screening)
  • negative urine and/or serum pregnancy test
  • subjects of reproductive potential must agree to use acceptable birth control method

Exclusion Criteria:

  • have a diagnosis of Acute Promyelocytic Leukemia (APL) as defined by the WHO
  • currently participating in or has participated in a study of an investigational agent or device within 4 weeks of treatment initiation
  • have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to treatment initiation
  • have prior monoclonal antibody within 4 weeks prior to study Day 1 or have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • have prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 have not recovered from adverse events due to previously administered agent(s)
  • have a known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
  • have known active central nervous system (CNS) involvement
  • have an active autoimmune disease requiring systemic treatment within the past 3 months
  • has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • have an uncontrolled, life-threatening active infection
  • have a history or current evidence of condition, therapy, or laboratory abnormality that would preclude study participation in the opinion of the treating investigator
  • have known psychiatric or substance abuse disorders that would interfere with cooperation with the trial requirements
  • is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
  • have received prior therapy with any antibody targeting the T-cell co-stimulation or checkpoint pathways
  • have a known history of HIV
  • have known active Hepatitis B or Hepatitis C
  • have received a live vaccine within 30 days prior to treatment initiation

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 identifier (NCT number): NCT02708641

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Contact: Rita Johnson, RN 412-647-8571

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United States, Pennsylvania
Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Rita Johnson, RN   
Sponsors and Collaborators
Michael Boyiadzis
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Principal Investigator: Michael Boyiadzis, MD, MHSc UPMC Hillman Cancer Center

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Responsible Party: Michael Boyiadzis, Associate Professor of Medicine, Division of Hematology Oncology, University of Pittsburgh Identifier: NCT02708641     History of Changes
Other Study ID Numbers: 15-101
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents