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A Study of Pembrolizumab for Patients With Thymic Epithelial Tumor

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ClinicalTrials.gov Identifier: NCT02607631
Recruitment Status : Not yet recruiting
First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Thymic Epithelial Tumors Drug: Pembrolizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm Drug: Pembrolizumab
treated with Pembrolizumab 200 mg every 3 weeks




Primary Outcome Measures :
  1. Response rate by RECIST 1.1 [ Time Frame: 24 months ]
    complete response plus partial response as determined by RECIST 1.1


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 months ]
  2. Progression free survival [ Time Frame: 24 months ]
    time from the on-study date to date of disease progression

  3. Overall survival [ Time Frame: 24 months ]
    time from the on-study date to death as a result of any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02607631


Contacts
Contact: Myung-Ju Ahn, Prof. 82-2-3410-3438 silkahn@skku.edu

Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Myung-Ju Ahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02607631     History of Changes
Other Study ID Numbers: 2015-04-132-005
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Myung-Ju Ahn, Samsung Medical Center:
Thymic epithelial tumors
Pembrolizumab

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Thymus Neoplasms
Neoplasms by Histologic Type
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Pembrolizumab
Antineoplastic Agents