drugset / Trial / NCT06422403

A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers

NCT06422403 ↗

Phase 2 Recruiting 360 enrolled National University Hospital, Singapore
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome.

Timeline

Start
2024-11-25
Primary completion
2029-03-30
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg —
Subject Bevacizumab Monoclonal antibody — —
Subject Nivolumab Monoclonal antibody 240 mg —
Subject Nivolumab Monoclonal antibody 360 mg —
Subject Pembrolizumab Monoclonal antibody 200 mg —