Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II, multi‑cohort trial of neoadjuvant and post‑surgery IO102‑IO103 and pembrolizumab in patients with selected resectable tumors

This study aims to find out if combining new drugs (IO102-IO103) with an existing cancer drug (Keytruda) works well for people with certain types of skin cancer (melanoma) or head and neck cancer. This treatment is given before surgery and sometimes afterwards too. Researchers will be looking at how much the tumors shrink before surgery and how patients recover after surgery. They will also carefully check for any side effects. This is a Phase II trial, meaning it's an early-stage study to see if the treatment is safe and effective enough to be studied in larger groups of people later on. Anyone aged 18 or over can be considered for the study.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

IO Biotech ApS

Enrolment target

Start

23 Aug 2023

Melanoma and squamous cell carcinoma of the head and neck

What is this study about?

This study is looking into new ways to treat two types of cancer: melanoma (a serious form of skin cancer) and squamous cell carcinoma of the head and neck (a type of cancer that can affect the mouth, throat, or voice box). The main idea is to give a combination of medicines before surgery, and sometimes after surgery, to see if it helps improve the chances of a successful treatment.

The treatment involves two new drugs called IO102-IO103, which will be given alongside a well-known cancer drug called Keytruda (its active ingredient is pembrolizumab). Doctors want to find out how well this combination shrinks the cancers before surgery. They'll be carefully checking the size of the tumour to see if it shrinks a lot or completely disappears before surgery, as this can lead to better outcomes.

After surgery, the doctors will continue to monitor the patients closely. They will also be recording any side effects that might happen, making sure the treatment is as safe as possible for patients. This is an important step in developing new cancer treatments, and the information gathered will help doctors understand if this new combination could be a good option for future patients.

Key takeaways

This study combines new drugs with Keytruda for two types of cancer.
Treatment is given before surgery, and sometimes after.
Aims to see how well the new combination shrinks tumours.
Also carefully checks for safety and side effects.
Open to adults aged 18 and over with specific cancer types.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would need to have been diagnosed with either melanoma (a type of skin cancer) or squamous cell carcinoma of the head and neck. Importantly, your cancer must be considered 'resectable', which means doctors believe it can be removed with surgery.

There will be other detailed medical checks to make sure the treatment is safe and suitable for you, and that you meet all the specific requirements of the study.

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.

Are you 18 years old or older?
Do you have melanoma or squamous cell carcinoma of the head and neck?
Is your cancer suitable for surgery?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medications (IO102-IO103 and Keytruda) before your surgery. These medicines are given as an infusion, which means they are delivered directly into your bloodstream, usually through a drip in your arm. Some patients may also receive the study medications after surgery.

You will have regular visits to the hospital or clinic to receive your treatment, have blood tests, and undergo scans or other tests to monitor your cancer and check for any side effects. Doctors will closely examine your tumour before surgery to see how it responds to the treatment. After surgery, you will have follow-up appointments to track your recovery and monitor your health over time. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from a new treatment that could be more effective for your cancer. However, the exact benefits are not yet fully known, as this is an early-stage study. There is a risk of side effects from the medications, such as those typically associated with cancer treatments, including infections, tiredness, or other unexpected reactions. The study team will carefully monitor you for these and provide support. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Spain
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Unverified
Germany
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Unverified
Denmark
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Unverified
France

Common questions

What kind of cancers is this study for?

This study is for people with melanoma (a type of skin cancer) or squamous cell carcinoma of the head and neck, where surgery is an option.

What drugs are being tested?

We are testing a combination of two new drugs, IO102-IO103, along with an existing cancer drug called Keytruda (pembrolizumab).

What does 'neoadjuvant treatment' mean?

Neoadjuvant treatment means you receive the study drugs before your surgery, to try and shrink the cancer first.

How long will I be in the study?

The exact length will depend on your treatment plan and follow-up schedule, but the study team will explain this in detail.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, and it won't affect your medical care.