Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Study of REGN6569 and Cemiplimab in Adult Patients with Advanced Solid Tumor Malignancies

This is an early research study, often called a Phase 1 trial, and it's the first time these specific medicines (REGN6569 and Cemiplimab) are being tested together in people. The main goal is to check if this new combination is safe and what dose might be best. It's for adults who have advanced head and neck squamous cell carcinoma. Researchers also want to see how the body handles these drugs and if they show any signs of helping. Taking part would mean trying a very new approach when other treatments might not have worked or are no longer suitable for your type of cancer. It's a vital step in learning about potential new treatments for the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

03 Sep 2024

Squamous Cell Carcinoma of Head and Neck

What is this study about?

This is an early research study, sometimes called a Phase 1 trial. It's designed to be the very first time that a combination of two new medicines, called REGN6569 and Cemiplimab, are given to people. The main aim of a study like this is to find out if the new combination is safe and to understand how the body reacts to it, including understanding what dose might be most effective.

The study is for adults who have a specific type of cancer called advanced head and neck squamous cell carcinoma. This means the cancer has spread or come back after previous treatments. Researchers are hoping to learn if this new treatment can help people in this situation. It's a crucial step in developing new medicines, as all new treatments must go through these early safety checks before they can be studied in more people.

While this study is primarily about safety and finding the right dose, researchers will also be looking to see if the treatment shows any early signs of benefit for the cancer. Your participation would help doctors understand if this new combination could become a new option for patients with head and neck squamous cell carcinoma in the future.

Key takeaways

This is an early (Phase 1) study for advanced head and neck squamous cell carcinoma.
It tests a new combination of medicines called REGN6569 and Cemiplimab.
The main goal is to check for safety and find the right dose.
It's for adults aged 18 and over, of all genders.
Participation involves regular hospital visits for treatment, tests, and monitoring.
There are potential benefits and risks, like any new treatment.

Who may be eligible?

This study is looking for adult patients, meaning anyone aged 18 years or older, regardless of how old they are. Both men and women are welcome to take part.

To be included, you must have advanced head and neck squamous cell carcinoma. This generally means your cancer has either spread to other parts of your body or has come back after you've had other treatments. Your medical team will be able to tell you if your specific situation fits these criteria.

There will be other detailed medical criteria that your doctor will need to check to make sure the study is safe and appropriate for you. For example, they will look at your overall health, any other medical conditions you have, and the results of certain blood tests.

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 a diagnosis of advanced head and neck squamous cell carcinoma?
Are you able to travel to study appointments?
Are you generally well enough to take part in a clinical trial?
Are you comfortable with receiving a new, experimental treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the new combination of medicines (REGN6569 and Cemiplimab) as part of the study. You'll have regular appointments at the hospital or clinic, which will include physical examinations, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits will be more frequent at the beginning of the study.

The total duration of your participation will depend on how you respond to the treatment and the study's design. You will continue treatment for as long as it is safe and helpful for you, or until the study's planned treatment period ends. Even after you stop receiving the study medicines, there will usually be follow-up appointments to check on your long-term health and any side effects.

Potential risks and benefits

As with any new treatment, there are potential benefits and potential risks. The potential benefit is that this new combination of medicines might help to control your cancer when other treatments have not been successful, or it might offer a new option. However, because this is a very early-stage study, the main goal is to understand safety, and we don't yet know how much it will help cancer patients. There's a risk of experiencing side effects, some of which could be serious, as these medicines are new. Your medical team will explain all known and potential risks in detail. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is 'advanced' head and neck squamous cell carcinoma?

This usually means the cancer has spread beyond where it started or has come back after previous treatments. Your doctor will explain if this applies to you.

What is a 'Phase 1' study?

It's the first step where a new medicine or combination is given to people. The main aim is to check if it's safe and to find the best dose, rather than primarily to see if it cures the disease.

What are REGN6569 and Cemiplimab?

These are the names of new medicines being tested together. They are designed to work in specific ways against cancer, but they are still in the early stages of research.

Will I definitely get the new medicines?

Yes, in this type of study, all participants are expected to receive the study medicines. There isn't a 'placebo' group in this particular early phase.

What if I experience side effects?

Your medical team will closely monitor you. They will provide care and support for any side effects you experience, and you can report any concerns at any time.