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Monoclonal Antibodies

RO7247669 for Melanoma

Phase 1 & 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status

Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 months

Awards & highlights

Study Summary

This trialtests a potential melanoma treatment to determine safe and effective dosages for future use.

Who is the study for?

This trial is for adults with unresectable or metastatic melanoma, who haven't had certain previous treatments. They must have measurable disease, be in good physical condition (ECOG 0-1), and have their major organs functioning well. Participants can't join if they've had anti-LAG3 therapy, ocular melanoma, recent serious health events like heart attacks or strokes, are pregnant/breastfeeding, or have active infections.Check my eligibility

What is being tested?

The study tests two doses of a new medication called RO7247669 to see how effective and safe it is for treating melanoma that cannot be removed by surgery or has spread. Researchers will also look at how the body processes the drug and its effects on the disease.See study design

What are the potential side effects?

While specific side effects of RO7247669 aren't listed here, similar drugs often cause immune-related reactions affecting various organs, infusion-related symptoms like fever or chills, fatigue, skin issues and may increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I know my cancer's BRAF V600 mutation status.

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My melanoma cannot be surgically removed and is classified as Stage III or IV.

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I am fully active or can carry out light work.

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I know my cancer's PD-L1 status.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Change from baseline in the number and activation of immune cells in the tumor microenvironment

Change from baseline in the number and activation status of peripheral blood immune cells

Disease control rate (DCR)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low dose every three weeks (Q3W)Experimental Treatment1 Intervention

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

Group II: High dose Q3WExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,143 Total Patients Enrolled

49 Trials studying Melanoma

58,424 Patients Enrolled for Melanoma

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,860 Total Patients Enrolled

50 Trials studying Melanoma

42,839 Patients Enrolled for Melanoma

Media Library

RO7247669 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05419388 — Phase 1 & 2

Melanoma Research Study Groups: High dose Q3W, Low dose every three weeks (Q3W)

Melanoma Clinical Trial 2023: RO7247669 Highlights & Side Effects. Trial Name: NCT05419388 — Phase 1 & 2

RO7247669 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05419388 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Q3W dosing a secure practice for individuals?

"In light of the fact this is a stage two trial, with safety being substantiated but efficacy not yet established, our team at Power assigned Low dose every three weeks (Q3W) a rating of 2 on their scale."

Answered by AI

Are there still vacancies for participants in this clinical trial?

"Affirmative. The details on clinicaltrials.gov suggest that this research is presently attempting to find eligible participants. This endeavor was initially published on August 15th 2022 and underwent its most recent update in January 2nd 2023, with an objective of finding 80 volunteers at a single medical centre."

Answered by AI

What is the enrollment quota for this trial?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is actively looking for volunteers and has been since August 15th 2022; most recently it was updated January 2nd 2023. All in all, 80 participants are needed from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma

2022. "A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05419388.