NCT02767934

Brief Summary

This phase II trial studies how well pembrolizumab works in treating small amounts of cancer cells that remain after attempts to remove the cancer has been made in patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

January 13, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 11, 2020

Completed
Last Updated

August 20, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

May 6, 2016

Results QC Date

July 20, 2020

Last Update Submit

August 11, 2020

Conditions

B Acute Lymphoblastic LeukemiaMinimal Residual DiseaseRecurrent Acute Lymphoblastic LeukemiaT Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Rate of Complete Minimal Residual Disease Response

    Will be defined as percentage of evaluable subjects who achieve a complete response. Will be evaluated with a Simon two-stage optimum design.

    Up to 2 years

Secondary Outcomes (2)

  • Overall Survival

    Up to 2 years

  • Relapse-Free Survival

    Up to 2 years

Study Arms (1)

Treatment (pembrolizumab)

EXPERIMENTAL

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator.

Other: Laboratory Biomarker AnalysisBiological: Pembrolizumab

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (pembrolizumab)
PembrolizumabBIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Treatment (pembrolizumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects must have a diagnosis of ALL of either B-cell, T-cell, or mixed (i.e., B/T lineage)
  • Be willing and able to provide written informed consent for the trial
  • Presence of MRD (defined as \< 5% blasts in the bone marrow by morphologic assessment and no clinically-apparent extramedullary disease but with quantifiably-measurable disease as assessed by either MFC or PCR) under any of the following circumstances:
  • MRD persistence \>= 11 weeks after the start of initial therapy
  • MRD persistence \>= 2 weeks after the start of salvage therapy, or
  • MRD reappearance at any time
  • For patients with Philadelphia chromosome positive (Ph+) disease, have previously received treatment with \>= 1 Abelson (ABL) kinase inhibitor (e.g., imatinib, dasatinib, etc.) or are ineligible for such treatment
  • Have previously received or are ineligible for treatment with blinatumomab; ineligibility will include (but not be limited to) cluster of differentiation 19 (CD19)-negative disease, denial of insurance coverage, physician discretion, and/or patient refusal
  • Be willing to provide tissue from a newly obtained bone marrow aspirate and/or biopsy; newly-obtained is defined as a specimen obtained up to 28 days prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the principal investigator (PI)
  • Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Absolute neutrophil count (ANC) \>= 1,000 /mcL (performed within 10 days of treatment initiation)
  • Hemoglobin \>= 8 g/dL (performed within 10 days of treatment initiation)
  • Platelets \>= 50,000 /mcL (performed within 10 days of treatment initiation)
  • Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance \>= 60 mL/min/1.73 m\^2 for subject with creatinine levels \> 1.5 X institutional ULN (performed within 10 days of treatment initiation) (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])
  • Serum total bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN (performed within 10 days of treatment initiation)
  • +6 more criteria

You may not qualify if:

  • Is currently participating and receiving study therapy or has participated in a study of an investigational new drug and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
  • Has a diagnosis of immunodeficiency 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 a known history of active bacillus tuberculosis (TB)
  • Has a known hypersensitivity to pembrolizumab or any of its excipients
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) 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 (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent
  • Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention (i.e., =\< grade 1 or at baseline) prior to starting therapy
  • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
  • Has known active central nervous system (CNS) leukemia and/or leukemic meningitis; subjects with previously treated CNS leukemia may participate provided they are stable (e.g., without evidence of active disease by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline) and have no evidence of leukemic blasts on analysis of cerebrospinal fluid (CSF)
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has known history of, or any evidence of active, non-infectious pneumonitis
  • Has previously received an allogeneic hematopoietic cell transplant, unless the following criteria are met:
  • Detection of MRD occurred \>= 21 days from stem cell infusion
  • No active GVHD
  • Receiving systemic steroid therapy of =\< 10 mg of prednisone daily (or equivalent)
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Cassaday RD, Garcia KA, Fromm JR, Percival MM, Turtle CJ, Nghiem PT, Stevenson PA, Estey EH. Phase 2 study of pembrolizumab for measurable residual disease in adults with acute lymphoblastic leukemia. Blood Adv. 2020 Jul 28;4(14):3239-3245. doi: 10.1182/bloodadvances.2020002403.

    PMID: 32692850DERIVED

MeSH Terms

Conditions

Burkitt LymphomaNeoplasm, ResidualPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaHematologic Diseases

Results Point of Contact

Title
Dr. Ryan Cassaday
Organization
University of Washington
cassaday@seattlecca.org
206-606-1202

Study Officials

  • Ryan Cassaday

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 11, 2016

Study Start

January 13, 2017

Primary Completion

July 31, 2019

Study Completion

December 17, 2019

Last Updated

August 20, 2020

Results First Posted

August 11, 2020

Record last verified: 2020-06

Locations

US(1)