This phase 1/2 trial is examining the effectiveness of durvalumab (Imfinzi) and monalizumab to treat patients with colorectal cancer or other solid tumors. The main outcomes to be measured are tumor response to the treatment and side effects.
Cancer is one of the leading causes of death worldwide. Chemotherapy is only of limited effectiveness in advanced cases. Therefore, the addition of other agents to the treatment is now more common. These drugs, such as immunotherapy, improve the treatment outcomes. However, it is still not clear how durvalumab and monalizumab work together to improve the outcomes of patients with advanced cancers.
This trial is examining the safety and effectiveness of durvalumab and monalizumab for the treatment of patients with advanced solid tumors, including colorectal cancer. The main outcomes evaluated will be side effects and response to treatment.
Who are they looking for?
This trial is recruiting 501 patients with advanced colorectal cancer or other solid tumors. Patients must have cancer that has come back after previous treatment or that has spread to other organs.
Patients must not have had prior treatment with immunotherapy agents. Must not have received an anticancer therapy within 4 weeks prior to this trial.
How will it work
This trial will have 3 parts. In part 1, all patients with solid tumors will receive different doses of durvalumab and monalizumab. After identifying the best dose, in part 2, all patients will receive further treatment with durvalumab and monalizumab. Part 3 will only include patients with colorectal cancer. They will receive durvalumab, monalizumab and standard therapy (with or without biological therapy). This will be followed by monalizumab combined with a biological agent.
Patients will be monitored for side effects, tumor response and survival for up to 5 years.