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

Recruiting now · Phase 1

Conditions studied: Esophageal and/or Cardia Cancer, Melanoma, Urothelial Carcinoma (UC)

In brief

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).

Key facts

Study ID

NCT07518043

Run by

Shanghai Henlius Biotech

People needed

174

Starts

2026-07-15

Expected to finish

2028-06-13

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Adequate recovery from prior surgery or systemic therapy.
• ECOG Performance Status of 0.
• Adequate organ function.
• Agreement to use effective contraception (negative pregnancy test for WOCBP).

You may not qualify if…

• 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.
• UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy.
• EC/GEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible).
• Prior treatment with nivolumab or any other immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4).
• Other primary active malignancies within 5 years or history of organ/bone marrow transplantation.
• Significant cardiovascular disease (MI, cerebrovascular disease) or unstable arrhythmia (QTc > 450ms/470ms) within 6 months.
• Chronic heart failure (NYHA Class III-IV) or LVEF < 50% at screening.
• Presence of interstitial pneumonia, pneumonitis, or severe lung function abnormalities.
• Active autoimmune disease requiring systemic immunosuppressive therapy.
• Known HIV infection, active Hepatitis B/C, or active pulmonary tuberculosis.
• Peripheral neuropathy ≥ Grade 2 or history of carcinomatosis meningitis.
• Use of systemic corticosteroids (>10 mg/day prednisone equivalent), immunosuppressants, or live vaccines within 28 days.
• Recent or planned participation in other investigational drug, device, or surgical studies.
• Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator.
• The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.

Where it is running

• Fujian Medical University Union Hospital — Fuzhou, China (enrolling)
• The First Affiliated Hospital Zhejiang University School Of Medicine — Hangzhou, China (enrolling)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, China (enrolling)
• The Second Hospital of Tianjin Medical University — Tianjin, China (enrolling)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China (enrolling)
• Union Hospital, Tongji Medical College,Huazhong University of Science and Technology — Wuhan, China (enrolling)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (enrolling)

Full record on ClinicalTrials.gov

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