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

NCT02708641 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 15-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• Time to Relapse (TTR)

  Time to recurrence of AML, including only deaths related to recurrence. Relapse of AML is defined as patients reaching remission (bone marrow contains \<5% blast cells, blood cell counts return to within normal limits, no signs disease) followed by a return of leukemia cells in the marrow and a decrease in normal blood cells.

  Up to 24 months

• Worst Grade of Adverse Events Experienced (Unrelated to Relatedness to Study Therapy)

  Worst Grade of AE experienced, regardless of relatedness to study therapy, per CTCAE v5.0.

  Up to 24 months

• Worst Grade of Adverse Events Experienced (at Least Probably Related to Treatment)

  Worst Grade of AE experienced, at least probably related to treatment, per CTCAE v5.0.

  Up to 24 months

Secondary Outcomes (1)

• Overall Survival (OS)

  Up to 48 months

Other Outcomes (5)

• Quantification of Activated T Cells

  Up to 24 months

• Quantification of Activated NK Cells

  Up to 24 months

• Quantification of Regulatory T Cells (Treg)

  Up to 24 months

Study Arms (1)

AML patients

EXPERIMENTAL

pembrolizumab 200 mg given IV once every three weeks

Drug: pembrolizumab

Interventions

pembrolizumab DRUG

200 mg IV given every three weeks

Also known as: Keytruda

AML patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Boyiadzis: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• Michael Boyiadzis, MD, MHSc

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Hematology Oncology

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 15, 2016
• Study Start: October 4, 2016
• Primary Completion: June 11, 2020
• Study Completion: December 1, 2020
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)