Actively Recruiting
A Study Comparing Standard and Extended Dosing of Nivolumab, Pembrolizumab, and Atezolizumab in Advanced Gastric, Hepatocellular, and Lung Cancers Phase 2 Randomized Trial
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
Researchers are evaluating the safety and effectiveness of standard dosing compared to extended dosing intervals of nivolumab, pembrolizumab, and atezolizumab in patients with advanced or unresectable cancers. These include gastric, gastroesophageal junction, and esophageal adenocarcinomas with PD-L1 CPS 25%, hepatocellular carcinoma, and non-small cell lung cancer with PD-L1 TPS 250%, with no prior treatment. This phase 2, open-label, multi-center study aims to determine if less frequent dosing can provide similar clinical outcomes as the approved dosing schedules. Participants are assigned to receive either standard dosing or extended dosing intervals of the drugs for up to two years. For example, nivolumab is given every 3 or 6 weeks combined with chemotherapy (XELOX or FOLFOX), atezolizumab with bevacizumab every 3 or 6 weeks, or pembrolizumab every 3 or 6 weeks. Each treatment group corresponds to a specific cancer type and drug combination. The study compares progression-free survival between these dosing schedules. Throughout the study, participants undergo assessments including imaging scans to measure tumors, laboratory tests to monitor organ function, and evaluations of side effects. Researchers track progression-free survival for up to two years and also assess overall survival and drug pharmacokinetics. Patients must attend scheduled visits and follow the protocol for treatment and evaluations to support study goals and safety monitoring.
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
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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
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