Status:
ACTIVE_NOT_RECRUITING
A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 sel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05419388
Start Date
August 15 2022
End Date
November 30 2025
Last Update
May 4 2025
Active Locations (22)
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1
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia, 2450
2
Melanoma Institute Australia
North Sydney, New South Wales, Australia, 2060
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
4
One Clinical Research
Nedlands, Western Australia, Australia, 6009