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New hope for advanced melanoma: experimental drug shows promise in early trial

NCT ID NCT05419388

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested two different doses of an experimental drug called RO7247669 in 93 people with advanced melanoma that had not been treated before. The goal was to see how well the drug controls the cancer and to find the best dose with the fewest side effects. Participants received the drug by infusion, and researchers measured how long the cancer stayed under control and how many people had their tumors shrink.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

93 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 2025

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: * Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV) * Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status * Adequate cardiovascular, hematological, hepatic and renal function * Willingness to abide by contraceptive measures for the duration of the study * Participants must have known PD-L1 status Exclusion Criteria: * Pregnancy, lactation, or breastfeeding * Known hypersensitivity to any of the components of RO7247669 * Participants must not have ocular melanoma * Symptomatic central nervous system (CNS) metastases * Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization * Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to randomization * Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study * Active or history of autoimmune disease or immune deficiency with some exceptions * Prior systemic anticancer therapy for unresectable or metastatic melanoma * Prior anticancer therapy with any-immunomodulatory agents including CPIs (such as anti-programmed death-ligand 1\[PD-L1\]/PD-1 and anti-cytotoxic T lymphocyte-associated antigen \[CTLA-4\]) with some exceptions if used as prior adjuvant or neoadjuvant melanoma therapies * Prior treatment with anti-LAG3 therapy

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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

  • Adana Baskent University Hospital

    Adana, 01120, Turkey (Türkiye)

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023, New Zealand

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450, Australia

  • District General Hospital of Athens Laiko

    Athens, 115 27, Greece

  • Hospital Clínic i Provincial

    Barcelona, 08036, Spain

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre, Rio Grande do Sul, DUMMY_VALUE, Brazil

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Medipol Mega Üniversite Hastanesi Göztepe

    Istanbul, 34214, Turkey (Türkiye)

  • Melanoma Institute Australia

    North Sydney, New South Wales, 2060, Australia

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Narodny Onkologicky Ustav

    Bratislava, 833 10, Slovakia

  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

    Warsaw, 02-781, Poland

  • One Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • POKO Poprad

    Poprad, 058 01, Slovakia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Všeobecná fakultní nemocnice v Praze

    Prague, 128 08, Czechia

  • Wellington Hospital

    Wellington, 6002, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.