NCT04295863

Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers

A Randomized Study Investigating the Pharmacokinetics of Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab Standard	For patients on standard schedule dosing of nivolumab, therapy will consist of 240mg IV once every 2 weeks or 480mg IV once every 4 weeks
DRUG	Pembrolizumab Standard	For patients on standard schedule dosing of pembrolizumab, therapy will consist of 200mg IV once every 3 weeks or 400mg IV once every 6 weeks
DRUG	Nivolumab Extended	For patients on extended interval dosing of nivolumab therapy will consist of 240mg IV once every 4 weeks or 480mg IV once every 8 weeks
DRUG	Pembrolizumab Extended	For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks

Timeline

• Start date: 2020-06-25
• Primary completion: 2026-04-12
• Completion: 2026-04-12
• First posted: 2020-03-05
• Last updated: 2025-10-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study