Active not recruitingPHASE3INTERVENTIONAL

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

This study is for people with advanced melanoma that has spread or can't be removed by surgery. It's testing a new approach by combining a trial drug, IO102-IO103, with a standard treatment, pembrolizumab. The researchers want to find out if this combination works better than pembrolizumab on its own for slowing down or stopping the cancer from growing. Participants will be randomly assigned to receive either the combination therapy or pembrolizumab alone. Both treatments are given through a drip, and IO102-IO103 also involves injections under the skin. The study will last up to two years, and doctors will carefully monitor participants’ health and cancer progression throughout.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

IO Biotech

Enrolment target

407

Start

17 May 2022

Estimated completion

01 Sep 2027

Metastatic Melanoma Unresectable Melanoma

What is this study about?

This clinical trial is designed for people who have advanced melanoma, which is a type of skin cancer that has spread to other parts of the body or cannot be completely removed by surgery. Doctors are looking for new and more effective ways to treat this condition.

The study aims to investigate whether a new experimental drug, called IO102-IO103, can improve treatment outcomes when given together with pembrolizumab. Pembrolizumab is a widely used and approved immunotherapy that helps your own immune system fight cancer. By combining it with IO102-IO103, researchers hope to give your body an even stronger defense against the cancer. Participants will be randomly put into one of two groups: one group will receive pembrolizumab on its own, and the other group will receive pembrolizumab plus IO102-IO103. This is done to fairly compare the two treatment approaches.

The main goal of the study is to see if the combination treatment can keep the cancer from growing or spreading for longer than pembrolizumab alone. This measure is called 'progression-free survival'. Researchers will also carefully monitor any side effects from the treatments and how they affect patients' overall health and well-being. This will help them understand if the new combination therapy is both effective and safe for future use.

Key takeaways

This study is for people with advanced melanoma that hasn't been treated yet.
It tests a new drug (IO102-IO103) combined with an existing one (pembrolizumab).
The goal is to see if the combination works better at stopping cancer growth.
Treatment can last up to two years and involves regular clinic visits.
You will be assigned to a treatment group randomly.

Who may be eligible?

To join this study, you must have advanced melanoma that can't be removed by surgery or has spread to other parts of your body. You should not have received any previous anti-cancer treatment for your advanced melanoma. However, if you had treatment in the past for an earlier stage of melanoma, you might still be eligible provided certain conditions are met, such as not having had that treatment within the last 6 months and your cancer not returning while on or shortly after that treatment.

Your doctors will also need to be able to measure at least one of your cancer spots on scans to track how the treatment is working. A recent tissue sample (biopsy) of your cancer and blood samples will also be needed for the study. If you have a specific genetic change in your melanoma called the 'BRAFV600 mutation', you can still join, but your doctors will need to confirm this before you start.

There are also some reasons why you might not be able to join. For example, if your melanoma has spread to your brain in an uncontrolled way or if it's the only place your cancer is active, you generally wouldn't be able to participate. However, if any brain spots are stable and have not grown for at least 4 weeks after treatment, and you haven't needed certain medications (like steroids) for them recently, you might still be considered. The study is open to both men and women aged 18 years and older.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced melanoma that can't be removed by surgery or has spread?
Have I had any previous treatment for my advanced melanoma?
Do scans show at least one cancer spot that can be measured?
Am I at least 18 years old?
Do I have any active cancer in my brain that is growing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will stay on treatment for up to two years. All participants will receive pembrolizumab through a drip into a vein every three weeks. If you are in the group receiving IO102-IO103, you will also get this drug through injections under your skin every three weeks. For the first two cycles of treatment (about 6 weeks), you'll have an extra dose of IO102-IO103 after your main treatment. You will have regular visits to the clinic for your treatments, check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These assessments will help the study doctors understand if the treatment is working and manage any side effects you might experience. The total duration of your active treatment would be a maximum of two years.

Potential risks and benefits

Participating in this trial could offer potential benefits, such as access to a new treatment combination that might be more effective than existing options for advanced melanoma. However, as with any medical treatment, there are potential risks and possible side effects from the drugs. These will be carefully explained to you by your doctor. It's important to remember that joining a clinical trial is always voluntary. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (112)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mid Florida Hematology and Oncology Center
Verified postcode
Orange City, United States
Orlando Health Cancer Institute
Verified postcode
Orlando, United States
Roswell Park Cancer Institute
Verified postcode
Buffalo, United States
VCU Massey Cancer Center
Verified postcode
Richmond, United States
Border Medical Oncology Research Unit
Verified postcode
Albury, Australia
Westmead Hospital
Verified postcode
Westmead, Australia
Southern Medical Day Care Centre
Verified postcode
Wollongong, Australia
Cairns Hospital
Verified postcode
Cairns, Australia
Flinders Medical Centre
Verified postcode
Bedford Park, Australia
The Queen Elizabeth Hospital
Verified postcode
Woodville South, Australia
Sunshine Coast University Hospital
Verified postcode
Birtinya, Australia
Peter MacCallum Cancer Centre PMCC - East Melbourne
Verified postcode
Melbourne, Australia

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that can spread to other parts of the body if not caught early.

What does 'advanced' or 'metastatic' melanoma mean?

This means the melanoma has spread from its original location to other parts of your body, or it's a type that doctors can't fully remove with surgery.

What is pembrolizumab?

Pembrolizumab is a type of immunotherapy that helps your own immune system fight cancer cells.

How long will I be on treatment in this study?

You could be on treatment for up to two years, depending on how you respond and your health.

Will I know if I'm getting the new drug or not?

This study is 'open-label', meaning both you and your doctor will know which treatment you are receiving.