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

Study acronym: VALUE-CHECK
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2025 to Nov 25, 2024
    • Site details revised
    v3
  2. Start date: Jul 1, 2024 to Jan 1, 2025
    • Enrollment target: 310 to 360
    • Study description shortened, about 33 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06422403
Lead Sponsor National University Hospital, Singapore
Conditions
(from sponsor)		 Carcinoma, Hepatocellular, Gastric Adenocarcinoma, GastroEsophageal Cancer, Oesophageal Cancer, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Related terms Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov