Search for predictors of immune checkpoint inhibitors in patients with malignant pleural mesothelioma

JRCT ID: jRCT1030210038

Registered date:14/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: malignant pleural mesothelioma
• Date of first enrollment: 17/07/2020
• Target sample size: 20
• Study type: Observational

Outcome(s)

Primary Outcome

Primary endpoint
The primary endpoint is the detection of immune complexes that correlate with the effects of immune checkpoint inhibitors. We plan to collect samples up to 4 times for each patient.
1) Samples can be collected 3 times or more.
2) It was possible to qualitatively and quantify immune complexes in the collected samples.
Patients who have achieved the above 1) and 2) are defined as events.

Secondary Outcome

Response Rate:RR
Progression free survival:PFS
Overall survival:OS
Number of immune complexes in serum in each case.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Patients with unresectable advanced/recurrent malignant pleural mesothelioma who have indication for treatment with immune checkpoint inhibitors and have measurable lesions by modified Response Evaluation Criteria in Solid Tumors (mRECIST).
2 Patients who are 20 years of age or older at the time of obtaining informed consent.
3 Patients who have received sufficient explanation before participating in this study, and who have obtained sufficient understanding and voluntary written informed consent of the patient. Patients who lack the ability to consent are not included.

Exclude criteria

1 Hepatitis B virus: HBs antigen or hepatitis C virus: HCV-RNA positive patients.
2 Patients with a positive human immunodeficiency virus (HIV) test.
3 Patients judged by the principal investigator or coordinator to be inappropriate as research subjects.
4 Patients who have received other immune checkpoint inhibitors, previously.

Related Information

• Primary Sponsor: Nakamura Yoichi