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

Phase 1

Active, not recruiting

• Conditions: Melanoma
• Interventions: Drug: RO7247669

• Registration Number: NCT05419388
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-15
• Study Start: 2022-08-15
• Primary Completion: 2024-05-01
• Disposition First Posted: 2025-01-20
• Status Verified: 2025-04
• Disposition First Submitted: 2025-04-30
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Percentage of Participants with Adverse Events	Up to 25 months
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

Trial Locations

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

Adana Baskent University Hospital; 🇹🇷 Adana, Turkey

Coffs Harbour Health Campus; 🇦🇺 Coffs Harbour, New South Wales, Australia

Melanoma Institute Australia; 🇦🇺 North Sydney, New South Wales, 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; 🇧🇷 Sao Paulo, São Paulo, Brazil

Hospital Sírio-Libanês; 🇧🇷 Sao Paulo, São Paulo, Brazil

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Auckland City Hospital, Cancer and Blood Research; 🇳🇿 Auckland, New Zealand

Memorial Ankara Hastanesi; 🇹🇷 Ankara, Turkey

Medipol Mega Üniversite Hastanesi Göztepe; 🇹🇷 Istanbul, Turkey