Your session is about to expire
← Back to Search
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 belowSelect...
I know my cancer's BRAF V600 mutation status.
Select...
My melanoma cannot be surgically removed and is classified as Stage III or IV.
Select...
I am fully active or can carry out light work.
Select...
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
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,312 Total Patients Enrolled
49 Trials studying Melanoma
58,198 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,956 Total Patients Enrolled
50 Trials studying Melanoma
42,613 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I know my cancer's BRAF V600 mutation status.I haven't had a major heart or stroke issue in the last 6 months.Your disease can be measured using specific guidelines for imaging.My melanoma cannot be surgically removed and is classified as Stage III or IV.I am fully active or can carry out light work.My heart, blood, liver, and kidneys are all functioning well.I have previously been treated with anti-LAG3 therapy.I have had treatment for melanoma that couldn't be removed by surgery.I know my cancer's PD-L1 status.I have or had an autoimmune disease or immune deficiency, with some exceptions.I have had cancer treatment with immune system drugs, except as early melanoma treatment.I do not have eye melanoma.I have symptoms from cancer spread to my brain.You are allergic to any parts of RO7247669.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I haven't had a serious infection or been hospitalized for one in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: High dose Q3W
- Group 2: Low dose every three weeks (Q3W)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger