Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 3-Arm, Randomized, Blinded, Active-Controlled, Phase II Study of RO7121661, a PD1-TIM3 Bispecific Antibody and RO7247669, a PD1-LAG3 Bispecific Antibody, Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

This study is for people in the UK with advanced or metastatic squamous cell cancer of the oesophagus. It's a Phase II trial, meaning researchers are looking at the treatments in more detail after early safety checks. The study aims to compare two new combination treatments (RO7121661 and RO7247669) with a standard treatment called Nivolumab. All these treatments are types of immunotherapy, which help your body's immune system fight cancer. The main goal is to find out if the new treatments can help people live longer than with the standard treatment. The study will also carefully check for side effects and how the treatments affect a person's quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

31 Oct 2024

Advanced or metastatic squamous cell carcinoma of the esophagus

What is this study about?

This clinical trial is designed to investigate new ways to treat a specific type of oesophageal cancer called advanced or metastatic squamous cell carcinoma. This means the cancer has spread beyond its original location. The study is comparing two new treatments, known for now by their codes RO7121661 and RO7247669, against a commonly used treatment called Nivolumab. All these treatments are immunotherapy drugs, which work by boosting your body's natural defences to fight cancer.

The main question this study hopes to answer is whether the new treatments can help people live longer compared to Nivolumab. The researchers will also be looking very closely at side effects, how well the treatments shrink or stop the cancer from growing, and importantly, how these treatments affect a person's quality of life – things like comfort, ability to do daily activities, and mental well-being.

This is a Phase II study, which means it's a step beyond the very first studies in people. In this phase, researchers are trying to get a better understanding of how well the new drugs work and continue to monitor their safety across a larger group of people. Participants will be randomly assigned to receive one of the three treatments, meaning it's like drawing straws, and neither you nor your doctor will get to choose which one you receive. This helps ensure the study results are fair and unbiased.

Key takeaways

Compares two new immune-boosting treatments against a standard one for advanced oesophageal cancer.
Aims to see if new treatments help people live longer and improve quality of life.
You will be randomly assigned to one of three treatments.
Close monitoring for side effects and how the treatment works.
Your health and comfort are very important throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. You need to have been diagnosed with advanced or metastatic squamous cell carcinoma of the oesophagus.

There will be other health requirements that your doctor will check. These usually involve your general health, blood test results, and how well your vital organs are working. These checks are important to make sure it's safe for you to take part and that the study results are reliable.

Your study doctor will go through all the specific entry requirements with you in detail. They will help you understand if this study might be a suitable option for your particular situation.

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 advanced or metastatic squamous cell cancer of the oesophagus?
Have you discussed your cancer treatment options with your doctor?
Are you able to attend regular hospital appointments for treatment and check-ups?
Are you prepared to answer questions about your health and feelings?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive one of the three treatments: RO7121661, RO7247669, or Nivolumab. This is like a lottery, and neither you nor your doctor will choose which treatment you get. Each treatment involves receiving medication, usually through a drip into your arm.

You will have regular visits to the hospital for your treatment and to have various tests. These tests may include blood samples, scans (like CT scans), and physical exams. These help the doctors monitor your health, how the treatment is working, and check for any side effects. You will also be asked to fill out questionnaires about your health and how you are feeling, which helps the researchers understand your quality of life.

The duration of your participation in the study will depend on how you respond to the treatment and your overall health. Your doctor will explain the full schedule of visits and tests to you, and what to expect during your time in the study.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is receiving treatment for your cancer and possibly having access to new therapies that are not yet widely available. The study aims to see if these new treatments can help you live longer or improve your quality of life. However, there's no guarantee that the treatment will work for everyone, or that it will be better than standard care. Like all medicines, the study treatments can cause side effects. These could range from mild to severe, and the study team will monitor you very closely for any issues. You will be given full information about the known side effects of each treatment before you decide to join. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Italy
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Unverified
Hungary
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Unverified
Denmark
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Unverified
France
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Unverified
Spain
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Unverified
Poland

Common questions

What is squamous cell carcinoma of the oesophagus?

It's a type of cancer that starts in the cells lining your oesophagus, which is the tube that carries food from your mouth to your stomach.

What does 'advanced or metastatic' mean?

It means the cancer has either grown into nearby tissues (advanced) or has spread to other parts of your body (metastatic).

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight the cancer cells. It's different from chemotherapy.

What does 'randomized' mean?

It means you will be put into one of the treatment groups by chance, like flipping a coin. Neither you nor your doctor will choose which treatment you get.

Will I know which treatment I am receiving?

This is a 'blinded' study, so you won't know which specific treatment you are getting. This helps make the study results more reliable.