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

Phase 1

Active, not recruiting

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Low dose every three weeks (Q3W)	RO7247669	Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
High dose Q3W	RO7247669	Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Up to 25 months
Serum concentration of RO7247669	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)
Objective response rate (ORR)	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)
Change from baseline in the number and activation status of peripheral blood immune cells	Baseline up to 25 months
Percentage of participants with anti-drug antibodies (ADAs)	Baseline up to 25 months
Percentage of Participants with Adverse Events	Up to 25 months

Locations (22): Princess Alexandra Hospital
🇦🇺
Woolloongabba, Queensland, Australia
Všeobecná fakultní nemocnice v Praze
🇨🇿
Prague 2, Czechia
District General Hospital of Athens Laiko
🇬🇷
Athens, Greece
Wellington Hospital
🇳🇿
Wellington, New Zealand
Uniwersyteckie Centrum Kliniczne
🇵🇱
Gda?sk, Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
🇵🇱
Warszawa, Poland
Narodny Onkologicky Ustav
🇸🇰
Bratislava, Slovakia
POKO Poprad
🇸🇰
Poprad, Slovakia
Hospital Universitari Vall d'Hebron
🇪🇸
Barcelona, Spain
Hospital Clínic i Provincial
🇪🇸
Barcelona, Spain
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Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia