A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
- Conditions
- nresectable or Metastatic MelanomaMedDRA version: 20.0Level: LLTClassification code: 10027481Term: Metastatic melanoma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505672-30-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 101
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. Participants must have known PD-L1 status
1. Pregnancy, lactation, or breastfeeding, 2. Participants must not have ocular melanoma, 3. Symptomatic central nervous system (CNS) metastases., 4. Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization, 5. Active or history of autoimmune disease or immune deficiency with some exceptions, 6. Prior systemic anticancer therapy for unresectable or metastatic melanoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method