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