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

JRCT ID: jRCT1030230268

Registered date:29/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neoplasms
• Date of first enrollment: 29/07/2023
• Target sample size: 400
• Study type: Observational

Outcome(s)

• Primary Outcome: The difference in the incidence of irAE between Nivolumab 2w and Nivolumab 4w groups, Pembrolizumab 3w and Pembrolizumabv 6w groups, respectively

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients treated with nivolumab monotherapy or pembrolizumab monotherapy at Kitasato University Hospital from April 1, 2019, to March 31, 2023

Exclude 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

Related Information

• Primary Sponsor: none none