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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Coffs Harbour Health Campus Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Unknown status |
| One Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Melanoma Institute Australia Coordinator of this site? Confirm its status | North Sydney | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Hospital de Cancer de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Hospital de Clínicas de Porto Alegre X Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sirio Libanes Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Auckland City Hospital, Cancer and Blood Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Wellington Hospital Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| National Oncology Institute Coordinator of this site? Confirm its status | Bratislava | Slovakia | Completed |
| POKO Poprad s.r.o. Coordinator of this site? Confirm its status | Poprad | Slovakia | Completed |
| Adana Baskent University Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Memorial Ankara Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Medipol Mega Üniversite Hastanesi Göztepe Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.