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RECRUITING
NCT06422403
PHASE2

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

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

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

Interventions

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)

Locations (1)

Department of Hematology-Oncology, National University Hospita

Singapore, Singapore