Not recruiting

Study of RO7247669 at Different Doses for People with Previously Untreated Advanced Melanoma that Cannot be Removed by Surgery or Has Spread

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying a new treatment for unresectable or metastatic melanoma, which is a serious form of skin cancer that has either spread to other parts of the body or cannot be removed by surgery. The study will test a medicine called RO7247669 (also known as TOBEMSTOMIG), which is a specialized antibody that targets specific proteins in the immune system.

The purpose of this research is to evaluate how well two different doses of RO7247669 work in people who have not received any previous treatment for their melanoma. The medicine will be given through intravenous infusion, which means it is delivered directly into a vein. Participants will receive either 600 mg or 1200 mg of the medication every three weeks.

During the study, participants will receive regular medical check-ups and scans to monitor their condition. The treatment period may last up to 24 months. The medicine being tested is designed to help the body's immune system fight against cancer cells by targeting two specific proteins called PD-1 and LAG3. This is different from traditional chemotherapy as it works by enhancing the body's natural defense mechanisms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your medical condition will be confirmed through a tissue examination (histology) to verify unresectable or metastatic melanoma
Your doctor will perform imaging tests to measure the disease according to RECIST criteria (a standardized way to measure tumors)
Your physical condition will be evaluated using the ECOG scale (a measure of your ability to perform daily activities)
Tests will be conducted to check your BRAF mutation status and PD-L1 status
Your heart, blood, liver, and kidney function will be evaluated
Step 2
Treatment assignment
You will be randomly assigned to receive RO7247669 at either:
- 600 mg every 3 weeks, or
- 1200 mg every 3 weeks
The medication will be given through an intravenous infusion (delivered directly into your vein)
Step 3
Treatment period
You will receive the assigned dose every 3 weeks
Regular imaging scans will be performed to monitor your response to treatment
Blood samples will be collected to measure drug levels and check for antibodies against the medication
Your blood will be tested to examine changes in your immune cells
If available, tumor samples may be analyzed to study changes in your cancer tissue
Step 4
Monitoring
Your doctor will check for any side effects throughout the treatment period
Side effects will be evaluated using standardized criteria
The treatment will continue until either:
- Your disease shows progression on scans
- You experience unacceptable side effects
- The study ends (estimated end date: November 2026)
Step 5
Follow-up
After stopping treatment, you will continue to be monitored for up to 60 days
Final assessments will be performed to evaluate your response to treatment
Any ongoing side effects will be followed until they resolve or stabilize

Who can join the trial?

11 criteria

You must be an adult aged 18 years or older
You must have unresectable or metastatic melanoma (skin cancer that cannot be surgically removed or has spread to other parts of the body) confirmed by tissue examination
Your cancer must be measurable through imaging tests according to RECIST criteria (standardized way to measure tumors)
Your physical ability status must be good, scoring either 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work) on the ECOG scale
You must have had testing to determine your BRAF V600 mutation status (a specific genetic change in the tumor)
You must have had testing to determine your PD-L1 status (a protein marker on cancer cells)
You must have normal:
- Heart function
- Blood cell counts
- Liver function
- Kidney function
- Both men and women may participate in this study

Who cannot join the trial?

12 criteria

History of severe allergic reactions to any medications or prior immunotherapy treatments
Active autoimmune diseases (conditions where the immune system attacks healthy cells) requiring systemic treatment
Active or untreated brain metastases (cancer that has spread to the brain)
Significant heart conditions including heart failure, unstable angina, or recent heart attack within the past 6 months
Active or chronic infections including hepatitis B, hepatitis C, or HIV
Previous treatment with similar immunotherapy medications in the past 4 weeks
Pregnancy or breastfeeding
Any other serious medical condition that could interfere with study participation
Current participation in other clinical trials
Unable to provide informed consent
History of other cancers within the past 3 years (except adequately treated non-melanoma skin cancer)
Severe liver or kidney dysfunction

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain
Laiko General Hospital Of Athens
Verified
Athens, Greece

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

RO7247669 is an investigational medication being studied for the treatment of melanoma (a type of skin cancer) that cannot be surgically removed or has spread to other parts of the body. This medication is being tested in patients who have not received any previous treatment for their condition. It is administered every three weeks and works by helping the body's immune system to fight cancer cells.

Ro7247669

What is already known about the treatment

RO7247669 – An investigational drug being studied in Phase II clinical trials for the treatment of unresectable or metastatic melanoma. This experimental medication is administered intravenously every three weeks at doses of either 600 mg or 1200 mg. While the exact molecular mechanism is still under investigation in clinical trials, it belongs to a class of targeted cancer therapies being evaluated for their effectiveness in treating advanced skin cancer. The primary goal of the current research is to determine how well this medication can prevent cancer progression in patients who have not received prior treatment for their melanoma.

Investigated diseases

Melanoma - A type of skin cancer that develops from melanocytes, the cells that produce melanin (skin pigment). When described as unresectable or metastatic, it means the cancer has either grown too large to be surgically removed or has spread to other parts of the body. The disease typically begins in a mole or appears as a new dark spot on the skin, which changes in size, shape, or color over time. It can develop anywhere on the body but is more common in areas exposed to sunlight. Melanoma can grow and spread rapidly through the lymphatic system and bloodstream to other organs.