New biosimilar aims to match cancer drug OPDIVO at lower cost

NCT ID NCT07518043

First seen Apr 10, 2026 · Last updated Jun 23, 2026 · Updated 12 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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

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.

Conditions

The condition(s) this trial relates to.

melanoma transitional cell carcinoma

As listed by the trial registrant

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