An exploratory prospective study of the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with Pembrolizumab.

An exploratory prospective study of the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with Pembrolizumab. - An exploratory study of immune-related adverse events in patients treated with Pembrolizumab.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028474

Enrollment

Registered

2017-08-01

Start date

2017-08-01

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

solid cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) ECOG performance status (PS) of 0 to 2. (2) Age of more than 20 years old. (3) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) HBs antigen, HCV antibody and HIV antibody is positive. (2) An inappropriate case judged by doctor in charge.

Design outcomes

Primary

Measure	Time frame
Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.	—

Secondary

Measure	Time frame
The elationship between peripheral blood T cell subsets and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate. The relationship between microflora of the gastrointestinal tract, oral cavity, and blood and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate. The relationship between PD-L1 expression of tumor tissue and predictions of therapeutic effect (response rate, 6-month progression free survival rate, and 1 year survival rate) and irAE.	—

Measure

Time frame

The elationship between peripheral blood T cell subsets and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate. The relationship between microflora of the gastrointestinal tract, oral cavity, and blood and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate. The relationship between PD-L1 expression of tumor tissue and predictions of therapeutic effect (response rate, 6-month progression free survival rate, and 1 year survival rate) and irAE.

—

Countries

Japan

Contacts

Public ContactKazuyuki Hamada

Showa University Department of Internal Medicine,Division of Medical Oncology

hamadakaz@med.showa-u.ac.jp03-3784-8402

Outcome results