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Could a cheaper keytruda copy work just as well for melanoma?

NCT ID NCT06153238

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study compares a new biosimilar drug (GME751) to the standard immunotherapy Keytruda in 322 adults with stage II or III melanoma that has been surgically removed. The goal is to see if the biosimilar stays in the body and works as well as Keytruda in preventing the cancer from coming back. Participants receive either drug as an infusion every few weeks, and researchers monitor drug levels, safety, and immune response.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

322 people

The number who actually took part.

Started

May 2024

Finished

May 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: * At least 18 years of age * Advanced Melanoma * Completely removed melanoma by surgery performed within 13 weeks of randomization * Adequate organ function * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Known history or evidence of ocular or uveal melanoma * Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients * Known History of auto-immune disease * Received live vaccine ≤30 days before the first study treatment * Prior treatment with anti-PD-1 agents or agent against another stimulatory or co-inhibitory T cell receptor * Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma 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

    Orange, California, 92868, United States

  • Sandoz Investigational Site

    Clermont, Florida, 34711, United States

  • Sandoz Investigational Site

    Orange City, Florida, 32763, United States

  • Sandoz Investigational Site

    Banja Luka, Bosnia and Herzegovina

  • Sandoz Investigational Site

    Mostar, Bosnia and Herzegovina

  • Sandoz Investigational Site

    Sarajevo, Bosnia and Herzegovina

  • Sandoz Investigational Site

    Tuzla, Bosnia and Herzegovina

  • Sandoz Investigational Site

    Barretos, Brazil

  • Sandoz Investigational Site

    Belo Horizonte, Brazil

  • Sandoz Investigational Site

    Canoas, Brazil

  • Sandoz Investigational Site

    Caxias do Sul, Brazil

  • Sandoz Investigational Site

    Curitiba, Brazil

  • Sandoz Investigational Site

    Florianópolis, Brazil

  • Sandoz Investigational Site

    Fortaleza, Brazil

  • Sandoz Investigational Site

    Itajaí, Brazil

  • Sandoz Investigational Site

    Porto Alegre, Brazil

  • Sandoz Investigational Site

    Porto Velho, Brazil

  • Sandoz Investigational Site

    Salvador, Brazil

  • Sandoz Investigational Site

    São José do Rio Preto, Brazil

  • Sandoz Investigational Site

    Besançon, France

  • Sandoz Investigational Site

    Nantes, France

  • Sandoz Investigational Site

    Batumi, Georgia

  • Sandoz Investigational Site

    Tbilisi, Georgia

  • Sandoz Investigational Site

    Mainz, Germany

  • Sandoz Investigational Site

    Münster, Germany

  • Sandoz Investigational Site

    Tübingen, Germany

  • Sandoz Investigational Site

    Catanzaro, Italy

  • Sandoz Investigational Site

    Rozzano, Italy

  • Sandoz Investigational Site

    Klaipėda, Lithuania

  • Sandoz Investigational Site

    Vilnius, Lithuania

  • Sandoz Investigational Site

    George Town, Malaysia

  • Sandoz Investigational Site

    Johor Bahru, Malaysia

  • Sandoz Investigational Site

    Kuala Lumpur, Malaysia

  • Sandoz Investigational Site

    Kuching, Malaysia

  • Sandoz Investigational Site

    Malacca, Malaysia

  • Sandoz Investigational Site

    Putrajaya, Malaysia

  • Sandoz Investigational Site

    Mexico City, Mexico

  • Sandoz Investigational Site

    Oaxaca City, Mexico

  • Sandoz Investigational Site

    San Luis Potosí City, Mexico

  • Sandoz Investigational Site

    Veracruz, Mexico

  • Sandoz Investigational Site

    Chisinau, Moldova

  • Sandoz Investigational Site

    Skopje, North Macedonia

  • Sandoz Investigational Site

    Bacolod, Philippines

  • Sandoz Investigational Site

    Bucharest, Romania

  • Sandoz Investigational Site

    Cluj-Napoca, Romania

  • Sandoz Investigational Site

    Belgrade, Serbia

  • Sandoz Investigational Site

    Kamenitz, Serbia

  • Sandoz Investigational Site

    Niš, Serbia

  • Sandoz Investigational Site

    Johannesburg, South Africa

  • Sandoz Investigational Site

    Phoenix, South Africa

  • Sandoz Investigational Site

    Badalona, Spain

  • Sandoz Investigational Site

    Barcelona, Spain

  • Sandoz Investigational Site

    Cáceres, Spain

  • Sandoz Investigational Site

    Madrid, Spain

  • Sandoz Investigational Site

    Murcia, Spain

  • Sandoz Investigational Site

    Santiago de Compostela, Spain

  • Sandoz Investigational Site

    Seville, Spain

  • Sandoz Investigational Site

    Valencia, Spain

  • Sandoz Investigational Site

    Zaragoza, Spain

  • Sandoz Investigational Site

    Ankara, Turkey (Türkiye)

  • Sandoz Investigational Site

    Yüreğir, Turkey (Türkiye)

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