Actively Recruiting
A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)
Led by National University Hospital, Singapore · Updated on 2025-01-10
360
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of standard versus extended dosing intervals of immune checkpoint inhibitors—nivolumab, pembrolizumab, and atezolizumab—in patients with advanced or unresectable cancers including gastric/gastroesophageal junction/esophageal adenocarcinomas with PD-L1 CPS ≥5%, hepatocellular carcinoma, and non-small cell lung cancer with PD-L1 TPS ≥50%, who have not received prior treatment. This phase 2, open-label, multi-center trial aims to see if less frequent dosing can maintain similar clinical outcomes. Participants will receive either standard or extended dosing of these drugs for up to two years. Treatments include combinations such as nivolumab with chemotherapy (XELOX or FOLFOX), atezolizumab with bevacizumab, or pembrolizumab alone. Standard dosing occurs every 2 to 3 weeks, while extended dosing occurs every 4 to 6 weeks, depending on the drug and cohort. The study has multiple groups assigned randomly to one of these dosing schedules. During the trial, participants will undergo regular assessments including imaging scans to measure disease progression, blood tests to monitor organ function and drug effects, and evaluations of side effects and overall survival. Researchers will track progression-free survival as the main outcome over up to two years, along with safety, response rates, duration of response, disease control, and pharmacokinetics. Follow-up visits and treatment adherence will be closely monitored throughout the study period.
CONDITIONS
Brief Title
A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Have one of the following untreated cancers: locally advanced/metastatic HER2-negative gastric/gastroesophageal junction/esophageal adenocarcinoma with PD-L1 CPS ≥5%; Child's A hepatocellular carcinoma; or locally advanced/metastatic lung adenocarcinoma with PD-L1 TPS ≥50% and EGFR/ALK wildtype
- Have measurable disease per RECIST 1.1 criteria
- Have an ECOG performance status of 0 to 2
- Have normal organ and bone marrow function within 28 days before study start
- Have life expectancy of at least 12 weeks
- Women of childbearing potential must use adequate contraception, have negative pregnancy test, or meet criteria for non-childbearing potential
- Male patients must be willing to use barrier contraception
- Willing to comply with the study protocol and attend all visits
- Have at least one lesion suitable for accurate measurement by CT or MRI
You will not qualify if you...
- Previous treatment with immune checkpoint inhibitors or investigational monoclonal antibodies
- Having a second primary cancer except certain treated cancers with no evidence for 5 years
- Unstable spinal cord compression or symptomatic brain metastases requiring steroids within 2 weeks
- Major surgery within 4 weeks before starting study treatment without full recovery
- Severe or uncontrolled systemic diseases including uncontrolled hypertension or active infections such as hepatitis B, C, or HIV
- Autoimmune disorders
- Pregnant or breastfeeding women or those not using effective contraception
- Judged unlikely to comply with study procedures
- Previous allogeneic bone marrow transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive immune checkpoint inhibitor drugs with either standard or extended dosing intervals for up to 2 years depending on their assigned cohort.
Visits every 3 to 6 weeks depending on dosing schedule
Trial Site Locations
Total: 1 location
1
Department of Hematology-Oncology, National University Hospita
Singapore, Singapore
Actively Recruiting
Research Team
W
Wei Peng Yong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here