CTIS2023-505672-30-00RecruitingPhase 1
A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants with Previously Untreated Unresectable or Metastatic Melanoma - BP43963
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 101
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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. Participants must have known PD-L1 status
Exclusion Criteria
- •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
Investigators
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