Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers Phase 2 Randomized Trial VALUE-CHECK
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALUE-CHECK
Brief 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 advancedunresectable gastricgastroesophageal junctionoesphageal adenocarcinomas with PDL1 CPS 5 hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS50 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 advancedunresectable gastricgastroesophageal junctionoesphageal adenocarcinomas with PDL1 CPS 5 hepatocellular carcinoma and non-small cell lung cancer with PDL1 TPS50
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None