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A Study of Pembrolizumab for Patients With Thymic Epithelial Tumor

Primary Purpose

Thymic Epithelial Tumors

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pembrolizumab
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymic Epithelial Tumors focused on measuring Thymic epithelial tumors, Pembrolizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be willing and able to provide written informed consent/assent for the trial.
  2. Be 18 years of age on day of signing informed consent.
  3. Histologically proven thymic epithelial tumor (TET) patients
  4. Inoperable or metastatic disease
  5. More than one previous chemotherapy including at least one platinum-based regimen
  6. At least one measurable lesion based on RECIST 1.1
  7. Patients who could submit at least one unstained slide to evaluate the PD-L1 expression status (PD-L1 status, which is positive (expression > 1percent of tumor cells) or negative, is the prerequiste for the enrollment. If the submitted slides are unacceptable for the analysis for PD-L1 and there is no remained slide, the patient cannot be enrolled)
  8. Have a performance status of 0 or 2 on the ECOG Performance Scale.
  9. Demonstrate adequate organ function as defined in Table 1. Laboratory test must be performed within 10 days before date of treatment.
  10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  11. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  12. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion Criteria:

  1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
  2. 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.
  3. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  4. Has an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
  5. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  6. Has an active infection requiring systemic therapy.
  7. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  8. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  9. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  10. Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  11. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
  12. Has known active tuberculosis which was not treated
  13. Has a known history of hypersensitivity to pemborolizumab
  14. Has a treatment history wih mAb within 4 weeks prior to the first dose of trial treatment
  15. Has had radiotherapy or chemotherapy within 14 days of the first does of trial treatment. Subjects who received radiotherapy >14 days prior to randomization must have completely recovered from any therapy related AEs/toxicities except peripheral neuropathy less than grade II
  16. Has a known history of psychosis or substance abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single arm

    Arm Description

    Pembrolizumab 200mg IV every 3 weeks until tumor progression or unacceptable toxicity

    Outcomes

    Primary Outcome Measures

    Response rate by RECIST 1.1
    complete response plus partial response as determined by RECIST 1.1

    Secondary Outcome Measures

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    include safety profiles
    Progression free survival
    time from the on-study date to date of disease progression
    Overall survival
    time from the on-study date to death as a result of any cause

    Full Information

    First Posted
    October 7, 2015
    Last Updated
    July 7, 2020
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02607631
    Brief Title
    A Study of Pembrolizumab for Patients With Thymic Epithelial Tumor
    Official Title
    A Phase II Study of Pembrolizumab for Patients With Thymic Epithelial Tumor Who Progressed After at Least One Previous Regimen of Cisplatin-Containing Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    February 2018 (Actual)
    Study Completion Date
    August 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a Phase II single center, open-label, single arm study in patients with advanced thymic epithelial tumors after failure of cisplatin-based combination chemotherapy. Patients will be treated with Pembrolizumab 200 mg every 3 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thymic Epithelial Tumors
    Keywords
    Thymic epithelial tumors, Pembrolizumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm
    Arm Type
    Experimental
    Arm Description
    Pembrolizumab 200mg IV every 3 weeks until tumor progression or unacceptable toxicity
    Intervention Type
    Drug
    Intervention Name(s)
    Pembrolizumab
    Intervention Description
    treated with Pembrolizumab 200 mg every 3 weeks
    Primary Outcome Measure Information:
    Title
    Response rate by RECIST 1.1
    Description
    complete response plus partial response as determined by RECIST 1.1
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Description
    include safety profiles
    Time Frame
    24 months
    Title
    Progression free survival
    Description
    time from the on-study date to date of disease progression
    Time Frame
    24 months
    Title
    Overall survival
    Description
    time from the on-study date to death as a result of any cause
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Be willing and able to provide written informed consent/assent for the trial. Be 18 years of age on day of signing informed consent. Histologically proven thymic epithelial tumor (TET) patients Inoperable or metastatic disease More than one previous chemotherapy including at least one platinum-based regimen At least one measurable lesion based on RECIST 1.1 Patients who could submit at least one unstained slide to evaluate the PD-L1 expression status (PD-L1 status, which is positive (expression > 1percent of tumor cells) or negative, is the prerequiste for the enrollment. If the submitted slides are unacceptable for the analysis for PD-L1 and there is no remained slide, the patient cannot be enrolled) Have a performance status of 0 or 2 on the ECOG Performance Scale. Demonstrate adequate organ function as defined in Table 1. Laboratory test must be performed within 10 days before date of treatment. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: Is currently participating in or has participated in a study of an investigational agent or using 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 additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Has an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. Has an active infection requiring systemic therapy. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Has received a live vaccine within 30 days prior to the first dose of trial treatment. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia Has known active tuberculosis which was not treated Has a known history of hypersensitivity to pemborolizumab Has a treatment history wih mAb within 4 weeks prior to the first dose of trial treatment Has had radiotherapy or chemotherapy within 14 days of the first does of trial treatment. Subjects who received radiotherapy >14 days prior to randomization must have completely recovered from any therapy related AEs/toxicities except peripheral neuropathy less than grade II Has a known history of psychosis or substance abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Myung-Ju Ahn, Prof.
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30647082
    Citation
    Kim KH, Cho J, Ku BM, Koh J, Sun JM, Lee SH, Ahn JS, Cheon J, Min YJ, Park SH, Park K, Ahn MJ, Shin EC. The First-week Proliferative Response of Peripheral Blood PD-1+CD8+ T Cells Predicts the Response to Anti-PD-1 Therapy in Solid Tumors. Clin Cancer Res. 2019 Apr 1;25(7):2144-2154. doi: 10.1158/1078-0432.CCR-18-1449. Epub 2019 Jan 15. Erratum In: Clin Cancer Res. 2020 Dec 15;26(24):6610.
    Results Reference
    derived

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    A Study of Pembrolizumab for Patients With Thymic Epithelial Tumor

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