Last updated: October 26, 2020
Sponsor: Tang-Du Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Carcinoma
Treatment
N/AClinical Study ID
NCT04554524
K202008-07
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Have a histologically or cytologically confirmed diagnosis of unresectable thymoma orthymic carcinoma.
- Have measurable disease based on RECIST 1.1.
- Patients must not have had prior systemic anti-cancer therapy for locally advanced ormetastatic 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 beperformed.
- 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 canalso 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 subjectswith 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 isreceiving anticoagulant therapy as long as PT or PTT is within therapeutic rangeof intended use of anticoagulants ≤ 1.5 X ULN unless subject is receivinganticoagulant therapy as long as PT or PTT is within therapeutic range ofintended use of anticoagulants.
- Female subject of childbearing potential should have a negative urine or serumpregnancy. If the urine test is positive or cannot be confirmed as negative, a serumpregnancy test will be required.
Exclusion
Exclusion Criteria:
- Patients have had prior systemic anti-cancer therapy.
- Has a known additional malignancy past 5 years. Exceptions include basal cellcarcinoma of the skin or squamous cell carcinoma of the skin that has undergonepotentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis. Subjects with previously treated brain metastases may participate providedthey are stable (without evidence of progression by imaging for at least four weeksprior to the first dose of trial treatment and any neurologic symptoms have returnedto baseline), have no evidence of new or enlarging brain metastases, and are not usingsteroids for at least 3 days prior to trial treatment.
- Hypersensitivity to carboplatin or paclitaxel or nab-paclitaxel or any of theirexcipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressivedrugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency, etc.) is not considered aform of systemic treatment.
- Asthmatic subjects requiring intermittent use of bronchodilators, inhaled steroids orlocal 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 withcooperation 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 theprojected duration of the trial.
Study Design
Total Participants: 40
Study Start date:
August 27, 2020
Estimated Completion Date:
July 30, 2024
Study Description
Connect with a study center
Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi
ChinaActive - Recruiting
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