Influence of dosing interval on immune-related adverse events and infusion reaction of nivolumab and pembrolizumab

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030230268

Enrollment

400

Registered

2023-07-29

Start date

2023-07-29

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

Neoplasms Neoplasms

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients treated with nivolumab monotherapy or pembrolizumab monotherapy at Kitasato University Hospital from April 1, 2019, to March 31, 2023

Exclusion criteria

Exclusion criteria: (i) Patients who switched from the old regimen to the new regimen (ii) Patients who could not continue more than 2 courses of the old regimen when only the old regimen was administered (iii) Patients with missing data in the survey items

Design outcomes

Primary

Measure	Time frame
The difference in the incidence of irAE between Nivolumab 2w and Nivolumab 4w groups, Pembrolizumab 3w and Pembrolizumabv 6w groups, respectively	—

Secondary

Measure	Time frame
The difference in time to onset of irAE between Nivolumab 2w and Nivolumab 4w groups, Pembrolizumab 3w, and Pembrolizumab 6w groups The difference in the incidence of infusion reaction between Nivolumab 2w and Nivolumab 4w groups and Pembrolizumab 3w and Pembrolizumab 6w groups, Incidence of irAE, time to irAE, and risk factors for infusion reaction	—

Contacts

Public ContactAtsushi Kawamura

Kitasato university hospital

a.kawa@kitasato-u.ac.jp+81-42-778-8111

Outcome results