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

Last updated: November 22, 2024
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Melanoma

Treatment

RO7247669

Clinical Study ID

NCT05419388
BP43963
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed unresectable or metastatic melanoma, per the American JointCommittee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)

  • Radiologically measurable disease according to Response Evaluation Criteria in SolidTumors (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

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 torandomization

  • Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, orother infection or any major episode of infection requiring treatment withintravenous (IV) antibiotics or hospitalization within 28 days prior torandomization

  • Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery duringthe 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 asanti-programmed death-ligand 1[PD-L1]/PD-1 and anti-cytotoxic Tlymphocyte-associated antigen [CTLA-4]) with some exceptions if used as prioradjuvant or neoadjuvant melanoma therapies

  • Prior treatment with anti-LAG3 therapy

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: RO7247669
Phase: 2
Study Start date:
August 15, 2022
Estimated Completion Date:
October 15, 2025

Connect with a study center

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • Melanoma Institute Australia

    North Sydney, New South Wales 2060
    Australia

    Site Not Available

  • Princess Alexandra Hospital; Cancer Trials Unit

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre, RS
    Brazil

    Completed

  • Hospital de Cancer de Barretos

    Barretos, SP 14784-400
    Brazil

    Site Not Available

  • Hospital Sírio-Libanês

    Sao Paulo, SP 01308-050
    Brazil

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Sao Paulo, SP 01246-000
    Brazil

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • Masarykuv onkologicky ustav

    Brno, 656 53
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Všeobecná fakultní nemocnice v Praze; Dermatovenerologická klinika

    Prague 2, 128 08
    Czechia

    Completed

  • District General Hospital of Athens Laiko; 1st Internal Medicine Clinic

    Athens, 115 27
    Greece

    Site Not Available

  • Theageneio Hospital

    Thessaloniki, 546 39
    Greece

    Site Not Available

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023
    New Zealand

    Completed

  • Wellington Hospital; Regional Oncology Unit

    Wellington, 6002
    New Zealand

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Pozna?, 60-780
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.

    Warszawa, 02-781
    Poland

    Site Not Available

  • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • POKO Poprad; Department of Oncology

    Poprad, 058 01
    Slovakia

    Completed

  • Hospital Clínic i Provincial; Servicio de Oncología

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron; Oncology

    Barcelona, 08035
    Spain

    Site Not Available

  • Clinica Universidad de Navarra Madrid; Servicio de Oncología

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034
    Spain

    Site Not Available

  • Adana Baskent University Hospital; Medical Oncology

    Adana, 01120
    Turkey

    Site Not Available

  • Memorial Ankara Hastanesi

    Ankara, 06520
    Turkey

    Site Not Available

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edirne, 22030
    Turkey

    Completed

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34000
    Turkey

    Completed

  • Medipol Mega Üniversite Hastanesi Göztepe

    Istanbul, 34214
    Turkey

    Completed

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.