NCT05419388

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2022

Typical duration for phase_2

Geographic Reach
10 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2025

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

June 13, 2022

Last Update Submit

January 28, 2026

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Percentage of Participants with Adverse Events

    Up to 25 months

  • Objective response rate (ORR)

    Up to 25 months

  • Disease control rate (DCR)

    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

  • +3 more secondary outcomes

Study Arms (2)

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.

Drug: RO7247669

High dose Q3W

EXPERIMENTAL

Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Drug: RO7247669

Interventions

RO7247669DRUG

Participants will receive intravenous (IV) RO7247669 Q3W

High dose Q3WLow dose every three weeks (Q3W)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, 2450, Australia

Location

Melanoma Institute Australia

North Sydney, New South Wales, 2060, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

One Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Hospital de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, DUMMY_VALUE, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Hospital Sírio-Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Všeobecná fakultní nemocnice v Praze

Prague, 128 08, Czechia

Location

District General Hospital of Athens Laiko

Athens, 115 27, Greece

Location

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand

Location

Wellington Hospital

Wellington, 6002, New Zealand

Location

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland

Location

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Narodny Onkologicky Ustav

Bratislava, 833 10, Slovakia

Location

POKO Poprad

Poprad, 058 01, Slovakia

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial

Barcelona, 08036, Spain

Location

Adana Baskent University Hospital

Adana, 01120, Turkey (Türkiye)

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Medipol Mega Üniversite Hastanesi Göztepe

Istanbul, 34214, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 15, 2022

Study Start

August 15, 2022

Primary Completion

May 1, 2024

Study Completion

November 27, 2025

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Locations

ES(2)PL(2)GR(1)NZ(2)CZ(1)TU(3)BR(4)CA(1)AU(4)SL(2)