NCT05116202

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab will be administered at a dose of 3 mg/kg IV on Day 1 of each 21 day cycle.
DRUG	Ipilimumab	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	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.

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-09-22
• Completion: 2024-05-28
• First posted: 2021-11-10
• Last updated: 2025-07-18
• Results posted: 2025-07-18

Locations

14 sites across 5 countries: United States, Australia, France, Italy, Spain

Regulatory

• FDA-regulated drug study