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NCT05419388CompletedPhase 2

A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Source: ClinicalTrials.gov · Last updated 4 Feb 2026

Brief summary (registry, in English)

The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
93 (actual)
First submitted
13 Jun 2022
Start date
15 Aug 2022
Primary completion date
1 May 2024
Lead sponsor
Hoffmann-La Roche
Diseases
Melanoma
NCT number
NCT05419388
EU CT number
2023-505672-30-00
EudraCT number
2022-000631-23

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 93
  • From 15 Aug 2022 to the primary completion date, 1 May 2024
  • 22 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Prior systemic anticancer therapy for unresectable or metastatic melanoma
  • Prior treatment with anti-LAG3 therapy

Other illness

  • Known hypersensitivity to any of the components of RO7247669
  • Active or history of autoimmune disease or immune deficiency with some exceptions

Lab values

  • 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

Other

  • Pregnancy, lactation, or breastfeeding
  • Participants must not have ocular melanoma
  • Symptomatic central nervous system (CNS) metastases

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Coffs Harbour Health Campus
Coordinator of this site? Confirm its status
Coffs HarbourAustraliaUnknown status
One Clinical Research
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Melanoma Institute Australia
Coordinator of this site? Confirm its status
North SydneyAustraliaUnknown status
Princess Alexandra Hospital
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaUnknown status
Hospital de Cancer de Barretos
Coordinator of this site? Confirm its status
BarretosBrazilUnknown status
Hospital de Clínicas de Porto Alegre X
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Hospital Sirio Libanes
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Laiko General Hospital of Athens
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AthensGreeceCompleted
Auckland City Hospital, Cancer and Blood Research
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AucklandNew ZealandUnknown status
Wellington Hospital
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WellingtonNew ZealandUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
National Oncology Institute
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BratislavaSlovakiaCompleted
POKO Poprad s.r.o.
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PopradSlovakiaCompleted
Adana Baskent University Hospital
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AdanaTurkey (Türkiye)Unknown status
Memorial Ankara Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Medipol Mega Üniversite Hastanesi Göztepe
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.