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

Melanoma Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419388
• Other study ID #: BP43963
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 15, 2022
• Est. completion date: October 15, 2025

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BP43963 https://forpatients.roche.com
• Phone: 1-888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W

Locations

Country	Name	City	State
Australia	Coffs Harbour Health Campus	Coffs Harbour	New South Wales
Australia	One Clinical Research	Nedlands	Western Australia
Australia	Melanoma Institute Australia	North Sydney	New South Wales
Australia	Princess Alexandra Hospital; Cancer Trials Unit	Woolloongabba	Queensland
Brazil	Hospital de Cancer de Barretos	Barretos	SP
Brazil	Hospital de Clínicas de Porto Alegre X	Porto Alegre	RS
Brazil	Hospital Sírio-Libanês	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	Všeobecná fakultní nemocnice v Praze; Dermatovenerologická klinika	Prague 2
Greece	District General Hospital of Athens Laiko; 1st Internal Medicine Clinic	Athens
Greece	Theageneio Hospital	Thessaloniki
New Zealand	Auckland City Hospital, Cancer and Blood Research	Auckland
New Zealand	Wellington Hospital; Regional Oncology Unit	Wellington
Poland	Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz	Gda?sk
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu	Pozna?
Poland	Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.	Warszawa
Slovakia	Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E	Bratislava
Slovakia	POKO Poprad; Department of Oncology	Poprad
Spain	Hospital Clínic i Provincial; Servicio de Oncología	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Oncology	Barcelona
Spain	Clinica Universidad de Navarra Madrid; Servicio de Oncología	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Turkey	Adana Baskent University Hospital; Medical Oncology	Adana
Turkey	Memorial Ankara Hastanesi	Ankara
Turkey	Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi	Edirne
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Medipol Mega Üniversite Hastanesi Göztepe	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Brazil,  Canada,  Czechia,  Greece,  New Zealand,  Poland,  Slovakia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants with Adverse Events		Up to 25 months
Secondary	Objective response rate (ORR)		Up to 25 months
Secondary	Disease control rate (DCR)		Up to 25 months
Secondary	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)
Secondary	Serum concentration of RO7247669		Up to 25 months
Secondary	Percentage of participants with anti-drug antibodies (ADAs)		Baseline up to 25 months
Secondary	Change from baseline in the number and activation status of peripheral blood immune cells		Baseline up to 25 months
Secondary	Change from baseline in the number and activation of immune cells in the tumor microenvironment		Baseline to Cycle 2 Day 9 (cycle = 21 days)