A Biomarker Study Using Tumor-infiltrating Regulatory T Cells to Predict the Efficacy to Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer and Malignant Melanoma

A Biomarker Study Using Tumor-infiltrating Regulatory T Cells to Predict the Efficacy to Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer and Malignant Melanoma - A Biomarker study of ICIs for non-small cell lung cancer and malignant melanoma

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044535

Enrollment

130

Registered

2021-09-01

Start date

2021-09-03

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

Non-Small Cell Lung Cancer or Malignant Melanoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with clinically significant suspicion of non-small cell lung cancer or malignant melanoma 2. Residual tissue from biopsies (or resections) performed for diagnostic purposes can be submitted 3. ICI is expected to be administered 4. Acquisition of written informed consent

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
To determine whether assessment of tumor-infiltrating PD-1 positive regulatory T cells (Treg) can be a predictive biomarker of ICI efficacy.	—

Secondary

Measure	Time frame
To determine whether other assessments in tumor-infiltrating T lymphocytes (TIGIT, LAG-3, CTLA-4, or other) are predictive biomarkers of ICI efficacy.	—

Countries

Japan

Contacts

Public ContactKiichiro Ninomiya

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Hematology, Oncology and Respiratory Medicine

kiichiro_nino@okayama-u.ac.jp086-235-7227

Outcome results