Search for predictors of immune checkpoint inhibitors in MSI-High cancer patients.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030210039

Enrollment

Registered

2021-04-14

Start date

2021-01-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MSI-High cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable advanced/recurrent malignant pleural mesothelioma who have indication for treatment with immune checkpoint inhibitors and have measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) Ver1.1. 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

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

Contacts

Public ContactYoichi Nakamura

Tochigi Cancer Center

yonakamu@tochigi-cc.jp+81-28-658-5151

Outcome results