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Cheaper cancer drug copy tested in melanoma trial – but study halted early

NCT ID NCT06587451

Disease control Sponsor: Sandoz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a biosimilar (JPB898) against the original immunotherapy Opdivo, both combined with Yervoy, in 52 adults with advanced melanoma that could not be surgically removed. The goal was to see if the biosimilar works just as well. However, the trial was terminated early, so the full results are not available.

What this could mean

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

Active substance
nivolumab biosimilar (JPB898) plus ipilimumab (Yervoy)
What this could lead to
If successful, this could show that a more affordable biosimilar works as well as the original drug for advanced melanoma.
What could go wrong
The trial was terminated early with only 52 participants, so results are limited. Biosimilars may not always match the original drug's effectiveness or safety.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

52 people

The number who actually took part.

Started

Dec 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Male or female participants must be 18 years or older. * Histologically confirmed melanoma. * Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing. * Sexually active participants must agree to use effective contraception. Exclusion Criteria * Active brain or leptomeningeal metastases unless stable for 8 weeks. * Ocular melanoma. * Prior active malignancy within the last year untreated or still requiring treatment. * Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment. * Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • Sandoz Investigational Site

    Santiago, Chile

  • Sandoz Investigational Site

    Athens, Greece

  • Sandoz Investigational Site

    Thessaloniki, Greece

  • Sandoz Investigational Site

    Pisa, Italy

  • Sandoz Investigational Site

    Vilnius, Lithuania

  • Sandoz Investigational Site

    Kuala Lumpur, Malaysia

  • Sandoz Investigational Site

    Pulau Pinang, Malaysia

  • Sandoz Investigational Site

    Putrajaya, Malaysia

  • Sandoz Investigational Site

    Bacolod, Philippines

  • Sandoz Investigational Site

    Warsaw, Poland

  • Sandoz Investigational Site

    Lisbon, Portugal

  • Sandoz Investigational Site

    Daejeon, South Korea

  • Sandoz Investigational Site

    Málaga, Spain

  • Sandoz Investigational Site

    Oviedo, Spain

  • Sandoz Investigational Site

    Santander, Spain

  • Sandoz Investigational Site

    Santiago de Compostela, Spain

  • Sandoz Investigational Site 1

    Santiago, Chile

  • Sandoz Investigational Site 1

    Busan, South Korea

  • Sandoz Investigational Site 2

    Tbilisi, Georgia

  • Sandoz Investigational Site 2

    Seoul, South Korea

  • Sandoz Investigational Site 2

    Madrid, Spain

  • Sandoz Investigational Site 2

    Valencia, Spain

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