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

Study results available
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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

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.

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05116202 on ClinicalTrials.gov