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A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers
Sponsor: National University Hospital, Singapore
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.
Official title: A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)
Key Details
Gender
All
Age Range
21 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2024-11-25
Completion Date
2029-12-31
Last Updated
2025-01-10
Healthy Volunteers
No
Conditions
Interventions
Extended Dosing Interval - A
Nivolumab 360mg 6 weekly (up to 2 years) + XELOX Nivolumab 240mg 4 weekly (up to 2 years) + FOLFOX
Extended Dosing Interval - B
Bevacizumab + Atezolizumab 1200mg 6 weekly (up to 2 years)
Extended Dosing Interval - C
Pembrolizumab 200mg 6 weekly (up to 2 years)
Standard of Care - A
Nivolumab 360mg 3 weekly (up to 2 years) + XELOX Nivolumab 240mg 2 weekly (up to 2 years) + FOLFOX
Standard of Care - B
Bevacizumab + Atezolizumab 1200mg 3 weekly (up to 2 years)
Standard of Care - C
Pembrolizumab 200mg 3 weekly (up to 2 years)
Locations (1)
Department of Hematology-Oncology, National University Hospita
Singapore, Singapore