RecruitingPhase 2NCT06422403

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)


Sponsor

National University Hospital, Singapore

Enrollment

360 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy less often (less frequent dosing) is just as effective as standard dosing for people with certain advanced cancers — including stomach, liver, and lung cancer. Reducing frequency could lower costs and side effects without compromising results. **You may be eligible if...** - You have not yet received treatment for your advanced cancer and fall into one of these groups: - Stomach or esophageal cancer (PDL1 positive) starting platinum chemotherapy and nivolumab - Liver cancer (Child's A, hepatocellular carcinoma) starting atezolizumab and bevacizumab - Lung adenocarcinoma (PDL1 high, no EGFR/ALK mutations) starting pembrolizumab - You can provide informed consent **You may NOT be eligible if...** - You have already received systemic treatment for your advanced cancer - You have active autoimmune disease or serious organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGExtended Dosing Interval - A

Nivolumab 360mg 6 weekly (up to 2 years) + XELOX Nivolumab 240mg 4 weekly (up to 2 years) + FOLFOX

DRUGExtended Dosing Interval - B

Bevacizumab + Atezolizumab 1200mg 6 weekly (up to 2 years)

DRUGExtended Dosing Interval - C

Pembrolizumab 200mg 6 weekly (up to 2 years)

DRUGStandard of Care - A

Nivolumab 360mg 3 weekly (up to 2 years) + XELOX Nivolumab 240mg 2 weekly (up to 2 years) + FOLFOX

DRUGStandard of Care - B

Bevacizumab + Atezolizumab 1200mg 3 weekly (up to 2 years)

DRUGStandard of Care - C

Pembrolizumab 200mg 3 weekly (up to 2 years)


Locations(1)

Department of Hematology-Oncology, National University Hospita

Singapore, Singapore

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NCT06422403


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