UnknownPhase 4

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

China40 participantsStarted 2020-08-27

Plain-language summary

This is an investigational, single arm study.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

Objective Response Rate.

Timeframe: After 4 cycles (each cycle is 21 days) treatment up to 4 years.

Trial details

NCT IDNCT04554524

SponsorTang-Du Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-30

Contact for this trial

Yongan Zhou

86-13700287519 Zhou.yongan@163.com

View on ClinicalTrials.gov More Thymoma and Thymic Carcinoma trials