Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505672-30-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose every three weeks (Q3W) | Experimental | Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. |
|
| High dose Q3W | Experimental | Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7247669 | Drug | Participants will receive intravenous (IV) RO7247669 Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Up to 25 months | |
| Objective response rate (ORR) | Up to 25 months | |
| Disease control rate (DCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coffs Harbour Health Campus | Coffs Harbour | New South Wales | 2450 | Australia | ||
| Melanoma Institute Australia |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 25 months |
| Duration of response (DOR) | From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months) |
| Serum concentration of RO7247669 | Up to 25 months |
| Percentage of participants with anti-drug antibodies (ADAs) | Baseline up to 25 months |
| Change from baseline in the number and activation status of peripheral blood immune cells | Baseline up to 25 months |
| Change from baseline in the number and activation of immune cells in the tumor microenvironment | Baseline to Cycle 2 Day 9 (cycle = 21 days) |
| North Sydney |
| New South Wales |
| 2060 |
| Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| One Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Hospital de Clínicas de Porto Alegre X | Porto Alegre | Rio Grande do Sul | DUMMY_VALUE | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Hospital Sírio-Libanês | São Paulo | São Paulo | 01308-050 | Brazil |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Všeobecná fakultní nemocnice v Praze | Prague | 128 08 | Czechia |
| District General Hospital of Athens Laiko | Athens | 115 27 | Greece |
| Auckland City Hospital, Cancer and Blood Research | Auckland | 1023 | New Zealand |
| Wellington Hospital | Wellington | 6002 | New Zealand |
| Uniwersyteckie Centrum Kliniczne | Gda?sk | 80-214 | Poland |
| Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Narodny Onkologicky Ustav | Bratislava | 833 10 | Slovakia |
| POKO Poprad | Poprad | 058 01 | Slovakia |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial | Barcelona | 08036 | Spain |
| Adana Baskent University Hospital | Adana | 01120 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi | Ankara | 06520 | Turkey (Türkiye) |
| Medipol Mega Üniversite Hastanesi Göztepe | Istanbul | 34214 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided