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

  • Melanoma
Trial Status:

Recruiting

This trial runs in
Countries
  • New Zealand
Trial Identifier:

NCT05419388 BP43963

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT05419388 , BP43963 Trial Identifier
      RO7247669 Treatments
      Melanoma Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

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