HLX18 vs OPDIVO for resected solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, parallel-arm Phase 1 study comparing HLX18 to OPDIVO in adults who have completely resected esophageal/ge GEJ cancer, melanoma, or urothelial carcinoma. It aims to compare pharmacokinetics, efficacy, safety, and immunogenicity between the two drugs. Participants must meet strict surgical and health criteria and will be assigned to one of two treatment arms in a blinded fashion. The trial is conducted under IRB/IEC approval across several Chinese centers with Shanghai Henlius Biotech as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must have signed and dated an IRB/IEC approved written informed consent form.
2. Aged 18 to 70 years at the time of signing the ICF.
3. 18 kg/m² ≤ BMI ≤ 30 kg/m² and 50 kg ≤ body weight ≤ 85 kg.
4. Histologically confirmed solid tumors (EC/GEJC, Melanoma, or UC) status post R0 resection.
5. For EC/GEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection.
6. For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins.
7. For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0).
8. Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization.
9. Adequate recovery from prior surgery or systemic therapy.
10. ECOG Performance Status of 0.
11. Adequate organ function.
12. Agreement to use effective contraception (negative pregnancy test for WOCBP).

Exclusion Criteria:

1. History of illicit drug use or alcohol abuse within 12 months prior to randomization.
2. Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma.
3. UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy.
4. EC/GEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible).
5. Prior treatment with nivolumab or any other immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4).
6. Other primary active malignancies within 5 years or history of organ/bone marrow transplantation.
7. Significant cardiovascular disease (MI, cerebrovascular disease) or unstable arrhythmia (QTc \> 450ms/470ms) within 6 months.
8. Chronic heart failure (NYHA Class III-IV) or LVEF \< 50% at screening.
9. Presence of interstitial pneumonia, pneumonitis, or severe lung function abnormalities.
10. Active autoimmune disease requiring systemic immunosuppressive therapy.
11. Known HIV infection, active Hepatitis B/C, or active pulmonary tuberculosis.
12. Peripheral neuropathy ≥ Grade 2 or history of carcinomatosis meningitis.
13. Use of systemic corticosteroids (\>10 mg/day prednisone equivalent), immunosuppressants, or live vaccines within 28 days.
14. Recent or planned participation in other investigational drug, device, or surgical studies.
15. Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator.
16. The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, China Recruiting
• The First Affiliated Hospital Zhejiang University School Of Medicine
  Hangzhou, China Recruiting
• The First Affiliated Hospital of Henan University of Science & Technology
  Luoyang, China Recruiting
• The Second Hospital of Tianjin Medical University
  Tianjin, China Recruiting
• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, China Recruiting
• Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
  Wuhan, China Recruiting

Study contacts

• Study coordinator: Chang Chen
• Email: chenthoracic@163.com
• Phone: +86 138 1686 9003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Melanoma treatment with immunotherapy guided by serial ctDNA testing

  This trial tests whether regular ctDNA blood tests during treatment can help tailor the plan for patients with advanced melanoma receiving nivolumab and ipilimumab.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07930182

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

• Non-invasive skin-tape test to detect melanoma using methylation biomarkers

  A non-invasive skin-tape test is being tried to see if it can detect melanoma in people who are about to have a biopsy for a suspicious pigmented lesion.

  Recruiting at 4 sites Mitra Bio · Ghent and 4 other locations · NCT07883954

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Trop2-targeted NIR-II probe to identify bladder cancer in ex vivo samples

  A phase 2 study tests whether a Trop2-targeted NIR-II fluorescent probe can highlight bladder cancer lesions on ex vivo bladder tissue from patients undergoing radical cystectomy.

  Recruiting Phase 2 Yunnan Cancer Hospital · Kunming, Yunnan · NCT07848854

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.