Actively Recruiting
A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers
Led by National University Hospital, Singapore · Updated on 2025-01-10
360
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 advanced cancers: HER2-negative gastric/gastroesophageal junction/esophageal adenocarcinoma with PD-L1 CPS 25% starting platinum doublet and nivolumab; Child's A hepatocellular carcinoma starting atezolizumab and bevacizumab; or lung adenocarcinoma with PD-L1 TPS 250%, EGFR/ALK wildtype, starting pembrolizumab monotherapy
- 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 the study, including hemoglobin 2 8.0 g/dL, ANC 2 1.5 x10^9/L, WBC 2 3x10^9/L, platelet count 2 100 x10^9/L, bilirubin 2 1.5 x ULN, AST/ALT 2 2.5 x ULN (or 2 5 x ULN if liver metastases present), and creatinine 2 1.5 x ULN
- Have a life expectancy of at least 12 weeks
- For females of childbearing potential, use effective contraception, not be breastfeeding, and have a negative pregnancy test before treatment
- Meet one of the following for non-childbearing potential: postmenopausal for 2 12 months if age 2 50, amenorrheic for 12 months with postmenopausal hormone levels if under 50, or documented irreversible surgical sterilization
- Male patients must be willing to use barrier contraception
- Be willing to comply with study protocol and scheduled visits
- Have at least one lesion suitable for accurate measurement by CT or MRI, not previously irradiated, with size criteria as specified
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors or investigational monoclonal antibody therapy
- Second primary cancer except adequately treated non-melanoma skin cancer, curatively treated in situ cervical cancer, or other solid tumors treated with no evidence of disease for 2 5 years
- Unstable spinal cord compression or symptomatic brain metastases requiring steroids within 2 weeks before treatment
- Major surgery within 4 weeks before starting study treatment
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding disorders, or active infections such as hepatitis B, hepatitis C, or HIV
- Autoimmune disorders
- Males and females of reproductive potential not using effective contraception; pregnant or breastfeeding females
- Investigator judgment that patient is 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
Trial Site Locations
Total: 1 location
1
Department of Hematology-Oncology, National University Hospita
Singapore, Singapore
Actively Recruiting
Research Team
W
Wei Peng Yong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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