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Immune checkpoint inhibitor drugs like Ipilimumab and Nivolumab can help some people with cancer, but they do not work for most. Immune cells need to connect and send signals to fight disease, and they turn on when the body senses infection. Alintegimod is a new pill that helps guide these cells that may help cancer treatment work better without serious side effects. If you want to join this study, you will first have a visit to see if you are a good fit. During this visit, you will have a physical exam, an ECG to check your heart function, and imaging (CT or MRI) to measure your tumor. You will also give blood and urine samples. If you qualify, you will have a catheter injection/infusion device implanted into your body so you can get the study medicines. There are two parts to this study. During the first part, you will get Alintegimod for 21 days, then you will get Alintegimod with Ipilimumab for four 21-day cycles, followed by Nivolumab for eleven 28-day cycles. You will know what study medicines you are getting. You will have 13 study visits during this part of the study. At these visits, most of the same tests and procedures that you did during your first visit will be repeated. The study team will also ask about any side effects from the study drugs. During the second part of the study, you will be randomly placed into one of three groups, like flipping a coin. The first group will get Alintegimod below the recommended dose. The second group will get Alintegimod at the recommended dose. The third group will get only Ipilimumab and Nicolumab. You will not know what study medicine you are getting. You will have 17 visits during the second part of the study. At these visits, most of the same tests and procedures that you did during the first part of the study will be repeated. The study team will also ask about any side effects from the study drugs. The study will last about 6-12 months depending on how you respond to the study drugs. You and your insurance will need to pay for your routine medical care. You will not be paid for being in this study.

Who can Participate

You may be able to join this study if you have a confirmed diagnosis of an advanced solid tumor that has spread or cannot be removed. Examples include melanoma, pleural mesothelioma, kidney cancer, some colorectal cancer, liver cancer, and certain lung cancer without specific gene changes. You may also join if the drug combination ipilimumab and nivolumab is FDA approved for your type of cancer. You can still join if you have already been treated with anti PD-1/PD-L1 therapies. You cannot join if your cancer has spread to your brain or the lining of the brain or spine cord (leptomeningeal disease). If your cancer spread to your brain in the past, you must have completed treatment and not have taken steroids for at least 2 weeks before joining this study. You also cannot join if you have taken part in another study using an investigational drug within 21 days of joining this study. The study team will review other requirements with you. You can find more details about who can join on Clinicaltrials.gov. Click the NCT number link below to learn more.

Study ID

More information available at ClinicalTrials.gov: NCT06362369