NCT06422403

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

A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to assess the noninferiority of progression free survival of standard dosing compared to extended dosing interval of nivolumab, pembrolizumab and atezolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma, and non-small cell lung cancer with PDL1 TPS≥50%. Secondary Objective * To investigate the safety, overall survival (OS) of ICI at extended dosing interval of the standard versus extended dosing interval groups. * To investigate the pharmacokinetics (PK) of nivolumab, atezolizumab or pembrolizumab.

Conditions

• Carcinoma, Hepatocellular
• Gastric Adenocarcinoma
• GastroEsophageal Cancer
• Oesophageal Cancer
• Non-small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Extended Dosing Interval - A	Nivolumab 360mg 6 weekly (up to 2 years) + XELOX Nivolumab 240mg 4 weekly (up to 2 years) + FOLFOX
DRUG	Extended Dosing Interval - B	Bevacizumab + Atezolizumab 1200mg 6 weekly (up to 2 years)
DRUG	Extended Dosing Interval - C	Pembrolizumab 200mg 6 weekly (up to 2 years)
DRUG	Standard of Care - A	Nivolumab 360mg 3 weekly (up to 2 years) + XELOX Nivolumab 240mg 2 weekly (up to 2 years) + FOLFOX
DRUG	Standard of Care - B	Bevacizumab + Atezolizumab 1200mg 3 weekly (up to 2 years)
DRUG	Standard of Care - C	Pembrolizumab 200mg 3 weekly (up to 2 years)

Timeline

• Start date: 2024-11-25
• Primary completion: 2029-03-30
• Completion: 2029-12-31
• First posted: 2024-05-21
• Last updated: 2025-01-10

Locations

1 site across 1 country: Singapore