Completed

Assessment of RO7247669 Efficacy and Safety in Unresectable or Metastatic Melanoma

Study Aim

This phase 2 study aims to evaluate the safety and effectiveness of RO7247669 in treating unresectable or metastatic melanoma, with a primary focus on progression-free survival.

What is being tested

RO7247669

Drug

Who is being recruted

Melanoma+9

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: August 2022

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2022

Actual date on which the first participant was enrolled.

This study focuses on a specific treatment for individuals diagnosed with unresectable or metastatic melanoma, a severe form of skin cancer that has spread. The treatment in question is RO7247669, and the study aims to find the most effective and safe dose for future use. This research holds significance as it could lead to improved care and treatment options for those battling this form of skin cancer.

Official TitleA Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

NCT05419388

Principal SponsorHoffmann-La Roche

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

93 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

7 inclusion criteria required to participate

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

Show More Criteria

11 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Group II

Experimental

Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Suspended

Coffs Harbour Health Campus

Coffs Harbour, AustraliaOpen Coffs Harbour Health Campus in Google Maps

Suspended

Auckland City Hospital, Cancer and Blood Research

Auckland, New Zealand

Suspended

Wellington Hospital

Wellington, New Zealand

Suspended

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Completed22 Study Centers