This study is being done in metastatic microsatellite stable colorectal cancer, which is a type of bowel cancer that has spread to other parts of the body and does not show a certain change in the tumor called microsatellite instability. The purpose of the study is to see whether adding INCA33890 to standard treatment works better than standard treatment alone.
The standard treatment in this study includes bevacizumab, oxaliplatin, fluorouracil, and calcium folinate. INCA33890 is given by vein, and the other medicines are also given as injections or infusions into a vein. People in the study are assigned by chance to one of two groups: one group receives INCA33890 with the standard treatment, and the other group receives placebo with the standard treatment. The study is blinded, which means the treatment group is not known to the people taking part or to the study team during the study.
After treatment starts, the study team follows how the cancer responds and how long the treatment helps keep the disease under control. The study also looks at how long people live and at side effects, which are unwanted health problems caused by a treatment.
Who Can Join the Study?
Be able to understand the study information and be willing to sign a written informed consent form (ICF), which is a document saying you agree to join the study after being informed about it.
Be 18 years of age or older when signing the informed consent form.
Have metastatic colorectal adenocarcinoma confirmed by tissue testing, meaning the cancer started in the colon or rectum and has spread to other parts of the body, and the diagnosis was proven by looking at cells or tissue under a microscope.
Have Stage IV disease that cannot be removed completely with surgery, meaning the cancer is not suitable for a surgery that could cure it.
Have no previous systemic treatment for unresectable or metastatic colorectal cancer, meaning no prior treatment that travels through the whole body, such as chemotherapy, for cancer that cannot be removed or has spread.
May have had neoadjuvant or adjuvant treatment in the past, which means treatment given before surgery or after surgery, as long as the cancer did not come back within 12 months after the last systemic treatment.
Have measurable disease on scans, meaning the cancer spots can be seen and measured by imaging tests according to the study rules.
Have adequate organ function, meaning the major organs needed for the study, such as the liver, kidneys, and bone marrow, are working well enough according to the study requirements.
Be willing to avoid becoming pregnant or fathering a child during the study, meaning participants must take steps to prevent pregnancy if this applies to them.
Who Cannot Join the Study?
Known MSI-H/dMMR status in the medical record. This means the cancer is known to have a certain genetic pattern that is not allowed in this study.
History of an organ transplant, including allogeneic stem cell transplantation (a stem cell transplant from another person).
Active autoimmune disease that needed whole-body treatment in the past 2 years, such as disease-modifying drugs, steroids, or immunosuppressive drugs. Replacement treatment is allowed.
Any important ongoing medical problem, or a medical problem that is not well controlled, as defined by the study rules.
Uncontrolled active hepatitis B or hepatitis C infection.
HIV positive, unless all of these are true: the CD4+ count is at least 350 cells/μL, the virus is not detectable in the blood, and the person is taking highly active antiretroviral therapy (a strong combination treatment for HIV).
Current use of long-term whole-body corticosteroids (steroid medicines), meaning more than 10 mg/day of prednisone or a similar dose.
Received a live vaccine within 28 days before the first study treatment. A live vaccine contains a weakened form of a germ.
Current use of any prohibited medication listed in the study rules.
Known complete DPD deficiency in the medical record. DPD is an enzyme the body uses to break down certain medicines.
BRAF V600E mutation in the medical record. This is a specific change in a cancer gene.
Another cancer within the past 2 years before joining the study.
Untreated or progressing CNS metastases. CNS means the brain and spinal cord. This includes new or growing brain metastases, or new nerve-related symptoms caused by brain or CNS metastases.
Tumor that is known to grow into or wrap around a major blood vessel, or any history of important bleeding from the tumor within 30 days before joining the study.
Treatment in the past 3 years with an anti–PD-(L)1 antibody, an anti–CTLA-4 antibody, or any other drug that targets T-cell costimulation or checkpoint pathways. These are immune-system treatments.
Side effects from past treatment that have not improved to Grade 1 or back to the person’s usual level. Grade 1 means mild side effects. Grade 2 or higher numbness or tingling in the hands or feet from past chemotherapy, such as oxaliplatin, is also not allowed.
Receiving any other cancer treatment at the same time, except for the treatments being studied.
Received thoracic radiation of more than 30 Gy within 6 months before the first study treatment. Thoracic radiation means radiation to the chest, and Gy is a unit used to measure radiation dose.
INCA33890 is the study drug being tested in this trial. It is given by intravenous infusion, meaning it goes directly into a vein through a drip. The study is checking whether adding INCA33890 to the usual treatment can help people with metastatic microsatellite stable colorectal cancer better than the usual treatment alone.
Bevacizumab is a medicine already used as part of the standard treatment in this trial. It is given by intravenous infusion. It helps slow the growth of cancer by blocking the blood supply that tumors need to grow.
Oxaliplatin is a chemotherapy medicine used as part of the usual treatment in this study. It is given by intravenous infusion. It works by damaging cancer cells so they can no longer grow and divide normally.
Fluorouracil is another chemotherapy medicine used in the standard treatment plan. It is given by infusion into a vein. It helps kill cancer cells or stop them from making new cells.
Calcium folinate is given together with fluorouracil as part of the standard chemotherapy treatment. It is given by injection. In this trial, it helps fluorouracil work better against the cancer.
Metastatic Microsatellite Stable Colorectal Cancer – This is colorectal cancer that has spread from the colon or rectum to other parts of the body. It begins in the lining of the large intestine and gradually grows deeper and may form tumors in nearby tissues and distant organs. The term microsatellite stable means the cancer cells do not show a specific pattern of DNA instability. As the disease progresses, the cancer can become more widespread and involve multiple areas of the body.
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