Chemotherapy Combined With Pembrolizumab in Treating Patients With Thymoma and Thymic Carcinoma

  • STATUS
    Recruiting
  • End date
    Jul 30, 2024
  • participants needed
    40
  • sponsor
    Tang-Du Hospital
Updated on 26 January 2021
cancer
serum pregnancy test
measurable disease
carcinoma
direct bilirubin
neutrophil count
pembrolizumab
chemotherapy regimen
aptt
solid tumors
thymic carcinoma
thymic neoplasm

Summary

This is an investigational, single arm study.

Description

Pembrolizumab is FDA approved and commercially available for treatment of many types of cancers. It is considered investigational to use chemotherapy combined with pembrolizumab to treat thymoma or Thymic carcinoma.

Subjects will be evaluated for eligibility during a 28-day screening period. Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

Up to 40 participants will be enrolled in this study.

Details
Condition Thymoma, Thymoma, Thymomas, thymic carcinoma
Treatment Chemotherapy+Pembrolizumab.
Clinical Study IdentifierNCT04554524
SponsorTang-Du Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a histologically or cytologically confirmed diagnosis of unresectable thymoma or thymic carcinoma
Have measurable disease based on RECIST 1.1
Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymoma or thymic carcinoma
Patients who could provision of archival to evaluate the PD-L1 expression status
Be 18 years of age on day of signing informed consent
Life expectancy > 3 months
Have a performance status (PS) of 0 or 1 on the ECOG PS
Demonstrate adequate organ function as defined below all screening labs should be performed
Hematological: absolute neutrophil count 1500/mcL; platelets 80000mcL; hemoglobin 9g/dL or 5.6 mmol/L without transfusion within 4 weeks
Renal: serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) 1.5 X upper limit of normal (ULN) OR 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Hepatic: serum total bilirubin 1.5 X ULN OR direct bilirubin ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) 2.5 X ULN OR 5 X ULN for subjects with liver metastases; albumin 2.5mg/dL
Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Female subject of childbearing potential should have a negative urine or serum pregnancy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Exclusion Criteria

Patients have had prior systemic anti-cancer therapy
Has a known additional malignancy past 5 years. 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) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 3 days prior to trial treatment
Hypersensitivity to carboplatin or paclitaxel or nab-paclitaxel or any of their excipients
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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Asthmatic subjects requiring intermittent use of bronchodilators, inhaled steroids or local steroid injections were not excluded
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Participated in any other pembrolizumab trials or was treated with pembrolizumab
Has an active infection requiring systemic therapy
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
As known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has evidence of interstitial lung disease or active, non-infectious pneumonitis
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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