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OpenTrials
Completed

NCT Number: NCT05419388

A 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7247669

Drug

Participants will receive intravenous (IV) RO7247669 Q3W

Primary outcomes

  1. 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)

Secondary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: Up to 25 months

  2. Objective response rate (ORR)

    Time frame: Up to 25 months

  3. Disease control rate (DCR)

    Time frame: Up to 25 months

  4. 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)

  5. Serum concentration of RO7247669

    Time frame: Up to 25 months

  6. Percentage of participants with anti-drug antibodies (ADAs)

    Time frame: Baseline up to 25 months

  7. Change from baseline in the number and activation status of peripheral blood immune cells

    Time frame: Baseline up to 25 months

  8. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 15, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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