A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors (NCT07518043) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
174 participantsStarted 2026-06-30
Plain-language summary
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must have signed and dated an IRB/IEC approved written informed consent form.
. Aged 18 to 70 years at the time of signing the ICF.
. 18 kg/m² ≤ BMI ≤ 30 kg/m² and 50 kg ≤ body weight ≤ 85 kg.
. Histologically confirmed solid tumors (EC/GEJC, Melanoma, or UC) status post R0 resection.
. For EC/GEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection.
. For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins.
. For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0).
. Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization.
Exclusion criteria
. History of illicit drug use or alcohol abuse within 12 months prior to randomization.
. Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUC0-28d
Timeframe: From time 0 to 28 days after the 1st dose(4 weeks)
2
AUCss
Timeframe: From time 0 to 28 days after the 4th dose(16 weeks)