Phase II trial of atezolizumab (MPDL3280A) plus carboplatin and paclitaxel in patients with metastatic or recurrent thymic carcinoma

Takehito Shukuya0 sites47 target enrollmentJune 18, 2022

Overview

No summary available.

Registry

who.int

Start Date

June 18, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Takehito Shukuya

•(1\) Thymic carcinoma diagnosed histologically.
•(2\) Diagnosed as Masaoka stage III/IVa/IVb ineligible for radical surgery or radiotherapy, or recurrence after radical surgery or radiotherapy.
•(3\) No history of drug therapy (cytotoxic anticancer drug, immunotherapy, etc.) for thymic carcinoma.
•\- However, if the subject received postoperative adjuvant chemotherapy after radical surgery or chemoradiotherapy and received cytotoxic anticancer drugs, the subject is eligible if at least 6 months have passed since the last administration of the drug therapy.
•(4\) Age at the time of enrollment is 20 years or older.
•(5\) ECOG Performance Status (PS) is 0 \- 1 at the time of enrollment.
•(6\) Patients must have measurable disease according to RECIST version 1\.1\.
•\- However, if only a lesion with a history of radiotherapy can be considered as a measurable lesion, the lesion may be considered as a measurable lesion if it shows a clear tendency to enlarge after radiotherapy.
•(7\) Laboratory tests performed within 14 days prior to registration meet the following criteria (The same day of the week two weeks prior is acceptable based on the registration date. Delay due to national holidays is acceptable).
•\- Neutrophil count: \>\=1,500 /mm3

•(1\) Active multiple primary neoplasms.
•\- Duplication of carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that is considered to be cured by local treatment is not included in active multiple primary neoplasms (duplication of carcinoma).
•(2\) The patient has symptomatic brain metastasis or carcinomatous meningitis.
•\- If brain metastases are present, the patient is eligible if asymptomatic or if more than 15 days have passed since local treatment and corticosteroids are less than 10 mg/day of prednisolone equivalent.
•(3\) Patients are eligible if they have undergone local treatment (radiotherapy: within 14 days, major surgery: within 28 days) within the specified number of days prior to enrollment.
•\- Radiotherapy: 15 days or more, major surgery: 29 days or more
•(4\) Patient has a local infection requiring drainage or other surgical procedures or an active systemic infection.
•(5\) Active hepatitis B, hepatitis C, or HIV infection.
•\- If the patient is HBs antigen negative and HBs antibody or HBc antibody positive, HBV DNA level is measured and the virus level is less than 20 IU/mL (1\.3 Log IU/mL), the patient is eligible.
•\- If the patient is positive for HCV antibody, he/she is excluded.