Phase 2 Trial Comparing Standard and Extended Dosing Intervals of Nivolumab, Pembrolizumab, and Atezolizumab in Advanced Gastric, Liver, and Lung Cancers

What this Trial Is About

Researchers are evaluating the safety and effectiveness of standard versus extended dosing intervals of immune checkpoint inhibitorsnivolumab, pembrolizumab, and atezolizumabin patients with advanced or unresectable cancers including gastricgastroesophageal junctionesophageal 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.

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