A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
NCT ID: NCT05419388
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
93 participants
INTERVENTIONAL
2022-08-15
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low dose every three weeks (Q3W)
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W
High dose Q3W
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W
Interventions
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RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Melanoma Institute Australia
North Sydney, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Hospital de Clínicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
District General Hospital of Athens Laiko
Athens, , Greece
Auckland City Hospital, Cancer and Blood Research
Auckland, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Uniwersyteckie Centrum Kliniczne
Gda?sk, , Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
Warsaw, , Poland
Narodny Onkologicky Ustav
Bratislava, , Slovakia
POKO Poprad
Poprad, , Slovakia
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clínic i Provincial
Barcelona, , Spain
Adana Baskent University Hospital
Adana, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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BP43963
Identifier Type: -
Identifier Source: org_study_id
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