For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)
  2. Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
  5. Adequate cardiovascular, hematological, hepatic and renal function
  6. Willingness to abide by contraceptive measures for the duration of the study
  7. Participants must have known PD-L1 status

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Pregnancy, lactation, or breastfeeding
  2. Known hypersensitivity to any of the components of RO7247669
  3. Participants must not have ocular melanoma
  4. Symptomatic central nervous system (CNS) metastases
  5. Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
  6. 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
  7. 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
  8. Active or history of autoimmune disease or immune deficiency with some exceptions
  9. Prior systemic anticancer therapy for unresectable or metastatic melanoma
  10. 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
  11. Prior treatment with anti-LAG3 therapy
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-662-6728Email iconEmail Study Center

Study Details


Contition

Melanoma

Age

18+

Phase

PHASE2

Participants Needed

80

Est. Completion Date

Oct 15, 2025

Treatment Type

INTERVENTIONAL


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov NCT Identifier

NCT05419388

Study Number

BP43963

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.