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

January 28, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Coffs Harbour Health Campus
      • North Sydney, New South Wales, Australia, 2060
        • Melanoma Institute Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, DUMMY_VALUE
        • Hospital de Clinicas de Porto Alegre X
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • São Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • São Paulo, São Paulo, Brazil, 01308-050
        • Hospital Sírio-Libanês
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • Czechia
      • Prague, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
  • Greece
      • Athens, Greece, 115 27
        • District General Hospital of Athens Laiko
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital, Cancer and Blood Research
      • Wellington, New Zealand, 6002
        • Wellington Hospital
  • Poland
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Narodny onkologicky ustav
      • Poprad, Slovakia, 058 01
        • POKO Poprad
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Adana Baskent University Hospital
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hastanesi
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol Mega Üniversite Hastanesi Göztepe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose every three weeks (Q3W)
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
Drug: RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W
Experimental: High dose Q3W
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
Drug: RO7247669
Participants will receive intravenous (IV) RO7247669 Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 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)
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

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: Up to 25 months
Up to 25 months
Objective response rate (ORR)
Time Frame: Up to 25 months
Up to 25 months
Disease control rate (DCR)
Time Frame: Up to 25 months
Up to 25 months
Duration of response (DOR)
Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)
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
Time Frame: Up to 25 months
Up to 25 months
Percentage of participants with anti-drug antibodies (ADAs)
Time Frame: Baseline up to 25 months
Baseline up to 25 months
Change from baseline in the number and activation status of peripheral blood immune cells
Time Frame: Baseline up to 25 months
Baseline up to 25 months
Change from baseline in the number and activation of immune cells in the tumor microenvironment
Time Frame: Baseline to Cycle 2 Day 9 (cycle = 21 days)
Baseline to Cycle 2 Day 9 (cycle = 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

November 27, 2025

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP43963
  • 2023-505672-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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