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New biosimilar aims to match cancer drug OPDIVO at lower cost

NCT ID NCT07518043

Recruiting now Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This Phase 1 trial tests whether HLX18, a biosimilar of the cancer drug OPDIVO, works similarly in people with esophageal, melanoma, or bladder cancer after their tumors have been surgically removed. About 174 participants will receive either HLX18 or OPDIVO to compare how the drug moves through the body, its safety, and its ability to prevent cancer from coming back. The study is not yet recruiting and is still in early stages.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
HLX18 (a biosimilar drug similar to nivolumab/OPDIVO)
What this could lead to
If successful, this could show that HLX18 works as well as OPDIVO, potentially offering a more affordable treatment option for certain cancers after surgery.
What could go wrong
This is an early Phase 1 study with only 174 participants, so results may not confirm effectiveness. The drug is a biosimilar, meaning it may not perform identically to the original, and side effects could be similar to OPDIVO, including immune-related reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

esophageal cancer gastroesophageal junction adenocarcinoma melanoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ESOPHAGEAL AND/OR CARDIA CANCER MELANOMA UROTHELIAL CARCINOMA (UC)

Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, China

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    RECRUITING

    Hangzhou, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    RECRUITING

    Luoyang, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, China

  • The Second Hospital of Tianjin Medical University

    RECRUITING

    Tianjin, China

  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

    RECRUITING

    Wuhan, China

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