Melanoma
Conditions
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 select the recommended dose for further development.
Interventions
DRUGRO7247669
Participants will receive intravenous (IV) RO7247669 Q3W
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events | Up to 25 months |
| Objective response rate (ORR) | Up to 25 months |
| Disease control rate (DCR) | Up to 25 months |
| Duration of response (DOR) | 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 | Up to 25 months |
| Percentage of participants with anti-drug antibodies (ADAs) | Baseline up to 25 months |
| Change from baseline in the number and activation status of peripheral blood immune cells | Baseline up to 25 months |
| Change from baseline in the number and activation of immune cells in the tumor microenvironment | Baseline to Cycle 2 Day 9 (cycle = 21 days) |
Countries
Australia, Brazil, Canada, Czechia, Greece, New Zealand, Poland, Slovakia, Spain, Turkey (Türkiye)
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed