Active not recruitingPHASE3INTERVENTIONAL

A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

This study is for people with advanced cancer in the stomach, where the gullet joins the stomach, or the gullet itself. This is for cancers that have spread to other parts of the body or can't be removed by surgery. Researchers are comparing a new combination of two drugs, domvanalimab and zimberelimab, given alongside standard chemotherapy. This new treatment will be compared against another treatment that uses a different drug called nivolumab, also with standard chemotherapy. The main goal is to find out if the new combination is more effective at treating these cancers.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Arcus Biosciences, Inc.

Enrolment target

1,040

Start

21 Nov 2022

Estimated completion

01 Jun 2026

Advanced Upper Gastrointestinal Tract Adenocarcinoma

What is this study about?

This clinical trial is designed for people who have advanced cancer affecting their upper digestive tract, specifically the stomach, the area where the gullet (oesophagus) meets the stomach, or the gullet itself. 'Advanced' means the cancer has spread to other parts of the body or is too far along to be removed with an operation. The main aim of this study is to explore if a new combination of medicines can help treat these cancers more effectively.

The study will involve two main groups. One group will receive a new combination of two drugs, domvanalimab and zimberelimab, along with standard chemotherapy. The other group will receive a drug called nivolumab, also with standard chemotherapy. Both domvanalimab and nivolumab are types of immunotherapy, which work by helping your body's own immune system fight the cancer. Zimberelimab is also an immunotherapy drug that works in a similar way. By comparing these treatments, doctors hope to find a better way to treat these types of cancer.

Understanding how well these new drug combinations work is very important. This research could lead to new treatment options for people with these specific cancers, potentially improving how well people respond to treatment and how long they live. The trial is 'Phase 3', which means it's a large study, and the treatments have already shown some promise in earlier, smaller studies.

Key takeaways

This study is testing new treatments for advanced upper gut cancers.
It combines new immunotherapy drugs with standard chemotherapy.
The aim is to find out if these new combinations are more effective.
You might receive a new drug combination or a currently approved one.
Close monitoring for side effects and cancer response is a key part of participating.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of advanced cancer in your stomach, where your gullet meets your stomach, or your gullet itself. This means the cancer shouldn't be able to be removed by surgery or has spread to other parts of your body. You also need to be generally well enough to take part in a study, as assessed by a doctor, and have at least one part of your cancer that can be measured to see if the treatment is working.

There are also some reasons why you might not be able to join. For example, if you have other serious medical conditions, such as severe heart problems, certain lung diseases, or if you've recently had a stroke. You cannot have had an organ transplant in the past, or a type of cancer that is HER2-positive. Also, if your cancer has spread to your brain and is causing symptoms, or if you've already had other treatments for this advanced cancer, you might not be eligible. If you have active infections or certain mental health conditions that would make it hard to follow the study rules, you might also be excluded.

Quick self-check

Do I have advanced stomach or gullet cancer that has spread or can't be operated on?
Am I generally well enough to take part in a study?
Have I not received any previous treatment for this advanced cancer?
Do I have any other serious health conditions like heart problems or certain lung diseases?
Do I have cancer that is HER2-positive, or cancer that has spread to my brain and is causing symptoms?
Am I able to understand and sign consent forms?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of the treatment groups (either the new combination with chemotherapy or nivolumab with chemotherapy). The study team will explain exactly what this means for you. You will have regular appointments for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor your general health. The specific schedule of visits and assessments will vary but will be clearly outlined by the study team.

You will receive the study medications (domvanalimab, zimberelimab, nivolumab, and chemotherapy drugs like capecitabine, fluorouracil, leucovorin, or oxaliplatin) according to a set plan. The treatment will continue for a period, and you'll have follow-up appointments even after treatment ends, to keep an eye on your health and the cancer. The total duration of your involvement could be several months or longer, depending on your response to treatment and the study's follow-up plan. All details will be given to you in the consent form.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that are not yet widely available, which could potentially work better than standard care for your specific cancer. However, there are no guarantees, and the new treatments may not work for everyone. Like all medicines, these drugs can have side effects, which the study team will explain in detail. These side effects can range from mild to serious, and they will be carefully monitored throughout the study. You will always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (168)

Research Site
Los Angeles, United States
Research Site
Orange, United States
Research Site
Santa Monica, United States
Research Site
New Haven, United States
Research Site
Washington D.C., United States
Research Site
Fort Myers, United States
Research Site
St. Petersburg, United States
Research Site
Tallahassee, United States
Research Site
Louisville, United States
Research Site
Louisville, United States
Research Site
New Orleans, United States
Research Site
Boston, United States

+156 more sites — see the official record for the full list.

Common questions

What type of cancer is this study for?

This study is for advanced cancer in the stomach, upper part of the gullet, or where the gullet joins the stomach, especially if it has spread or cannot be removed by surgery.

What are the new treatments being tested?

The study is testing a new combination of two drugs, domvanalimab and zimberelimab, along with standard chemotherapy, against another immunotherapy drug called nivolumab with chemotherapy.

What does 'Phase 3' mean?

Phase 3 is a large study that compares new treatments with existing ones to confirm if they are safe and more effective, usually with many participants.

Will I know which treatment I'm getting?

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

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and your medical care will not be affected.