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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Participants will receive intravenous (IV) RO7247669 Q3W
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Progression-free survival (PFS)
Time frame: From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months)
Percentage of Participants with Adverse Events
Time frame: Up to 25 months
Objective response rate (ORR)
Time frame: Up to 25 months
Disease control rate (DCR)
Time frame: Up to 25 months
Duration of response (DOR)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months)
Serum concentration of RO7247669
Time frame: Up to 25 months
Percentage of participants with anti-drug antibodies (ADAs)
Time frame: Baseline up to 25 months
Change from baseline in the number and activation status of peripheral blood immune cells
Time frame: Baseline up to 25 months
Change from baseline in the number and activation of immune cells in the tumor microenvironment
Time frame: Baseline to Cycle 2 Day 9 (cycle = 21 days)
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