Substudy 1: Metastatic Colorectal Cancer Without Liver Metastases: A Phase II, Open-Label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants with Colorectal Cancer (CANTOR)

Colorectal cancer (also known as bowel cancer) is the 4th most common cancer in the UK. Almost 44,000 people are diagnosed with bowel cancer every year in the UK. It can affect anyone, but more than 90% of new cases are in people over the age of 50. 1 in 17 men and 1 in 20 women will be diagnosed with bowel cancer during their lifetime.Current treatments available for colorectal cancer are surgery, chemotherapy, radiotherapdy and targeted medicines. There is still an unmet need for further treatments.Cancer cells may stay in the bowel or they might spread to other parts of the body, such as the liver or lungs. Sub-Study 1 will recruit participants with metastatic colorectal cancer that hasn’t spread to the liver.The aim is to learn more about the effectiveness and safety of volrustomig when it is given in combination with a standard treatment for colorectal cancer.Volrustomig may help the immune system fight cancer by sticking to and blocking signaling from two molecules called PD-1 and CTLA-4. Cancer cells use PD-1 and CTLA-4 to avoid being attacked by the immune system. By stopping cancer cells from using these molecules, volrustomig may help the immune system to find and attack cancer cellsParticipants will be randomly assigned to either Arm A (volrustomig + standard treatment) or Arm B (standard treatment). They will have a 2 in 3 chance of being given volrustomig and both the participant and the study doctor will know which treatment is being administered. Study treatments will be administered by intravenous (IV) infusion over a 14-day cycle.About 120 participants in 12 countries at 75 study sites will take part in this study.This study is being sponsored by AstraZeneca AB.