A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
NCT05116202 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2025-07-18
Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.
Conditions
Interventions
- DRUG
-
Nivolumab will be administered at a dose of 3 mg/kg IV on Day 1 of each 21 day cycle.
- DRUG
-
Ipilimumab will be administered at a dose of 1 mg/kg by IV on Day 1 of each 21 day cycle.
- DRUG
-
RO7247669 2100 mg
RO7247669 will be administered at a dose of 2100 mg by IV infusion on Day 1 of each 21 day cycle.
- DRUG
-
Atezolizumab will be administered at a dose of 1200 mg IV on Day 1 of each 21 day cycle.
- DRUG
-
Tiragolumab
Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21 day cycle.
- DRUG
-
RO7247669 600 mg
RO7247669 will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-02
- Primary Completion
- 2023-09-22
- Completion
- 2024-05-28
- FDA Drug
- Yes
Countries
- United States
- Australia
- France
- Italy
- Spain
Study Locations
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