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Thymic Epithelial TumorsPhase 2NCT02607631

A Study of Pembrolizumab for Patients With Thymic Epithelial Tumor

A Phase 2 study testing Pembrolizumab in people with Thymic Epithelial Tumors, run by Samsung Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thymic Epithelial Tumors
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
Nov 2015to Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

About this study

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

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.

Being tested
Pembrolizumab
Keywords
Thymic epithelial tumors, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02607631
Study groupRoleWhat they receive
Single armExperimentalPembrolizumab 200mg IV every 3 weeks until tumor progression or unacceptable toxicity
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate by RECIST 1.1

    complete response plus partial response as determined by RECIST 1.1

    Measured: 24 months

Secondary outcomes (3)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    include safety profiles

    Measured: 24 months

  2. Progression free survival

    time from the on-study date to date of disease progression

    Measured: 24 months

  3. Overall survival

    time from the on-study date to death as a result of any cause

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionFeb 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02607631
Sponsor's protocol ID
2015-04-132-005
Status last verified
Jul 2020
First submitted
7 Oct 2015
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30647082

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Thymic Epithelial Tumors, run by Samsung Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate by RECIST 1.1 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02607631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.

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