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

NCT07518043 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HLX18-MRST001
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Esophageal and/or Cardia Cancer; Melanoma; Urothelial Carcinoma (UC)

Outcome Measures

Primary Outcomes (2)

• AUC0-28d

  From time 0 to 28 days after the 1st dose(4 weeks)

• AUCss

  From time 0 to 28 days after the 4th dose(16 weeks)

Secondary Outcomes (8)

• maximum serum drug concentration (Cmax)

  up to 16 weeks

• trough serum drug concentration (Ctrough)

  up to 16 weeks

• maximum serum drug concentration at steady state (Cmax,ss)

  up to 16 weeks

• trough serum drug concentration at steady state (Ctrough,ss)

  up to 16 weeks

• Disease-free survival (DFS)

  up to 12 months

Study Arms (2)

HLX18

EXPERIMENTAL

Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle, until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).

Drug: HLX18

OPDIVO®

ACTIVE COMPARATOR

Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle, for a total of 4 cycles (16 weeks). After 4 cycles, all participants in the OPDIVO® group will receive HLX18 480 mg on Day 1 of each 4-week cycle until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).

Drug: OPDIVO®

Interventions

HLX18 DRUG

Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle

HLX18

OPDIVO® DRUG

Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle

OPDIVO®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

MeSH Terms

Conditions

Melanoma; Carcinoma, Transitional Cell

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Chang Chen

CONTACT

+86 138 1686 9003; chenthoracic@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): August 12, 2027
• Study Completion (Estimated): June 13, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share