Phase I Study Comparing HLX18 and OPDIVO in Adults With Resected Esophageal, Melanoma, or Urothelial Cancers

What this Trial Is About

Researchers are conducting a multicenter, randomized, double-blind phase I study to compare HLX18 and OPDIVO in patients who have had surgery for esophageal or gastroesophageal junction cancer, melanoma, or urothelial carcinoma. The study aims to evaluate the pharmacokinetics, effectiveness, safety, and immune response of the two treatments. Participants include adults aged 18 to 70 years with specific tumor types that have been surgically removed with no disease recurrence. Participants will be assigned to receive either HLX18 or OPDIVO. Those in the HLX18 group will receive a 480 mg dose on Day 1 of each 4-week cycle for up to 12 months or until certain conditions occur, such as disease recurrence or unacceptable side effects. Participants in the OPDIVO group will receive 4 cycles of 480 mg doses every 4 weeks, then switch to HLX18 under the same schedule for the remainder of the study period. During the study, participants will undergo regular assessments including blood tests to measure drug levels, monitoring for side effects, physical exams, imaging to confirm disease status, and tests for immune reactions up to 24 weeks. Safety follow-up will continue for up to 15 months. The main outcomes measured include drug concentration over time and disease-free survival up to 12 months. The study will last until June 2028, with continuous monitoring throughout.

A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors