This phase 1/2 trial is examining the effectiveness of a new immunotherapy in the treatment of patients with advanced colorectal cancer (CRC). The main outcome to be measured will be tumor response to the treatment. This study is being conducted in Texas, USA.
CRC is the third most common cancer worldwide. The 5-year survival of patients with metastatic (spread to other parts of the body) CRC is 14%. The standard treatment for patients with operable advanced CRC is surgery and chemotherapy. However, chemotherapy is only of limited effectiveness in advanced cases. The addition of new drugs such as immunotherapy to the treatment might improve the chemotherapy effect. Immunotherapy helps the immune system to attack and kill cancer cells. Prior studies showed that the use of anti-PD1 immunotherapy improves cancer treatment. M7824 is a new immunotherapy drug currently in development.
This trial is evaluating the safety and effectiveness of M7824 for the treatment of patients with advanced CRC. The main outcome measured will be tumor response.
Who are they looking for?
This trial is recruiting 74 patients with inoperable advanced CRC. Patients must have progressed after at least 2 prior treatments, must have a life expectancy of more than 12 weeks and normal bone marrow, liver, and kidney function. All patients must use effective birth control during the study and up to 4 months after stopping the treatment.
Patients must not be currently being treated or have had anticancer treatment within 14 days prior to this trial, surgery within 28 days not immunosuppressive treatment within 7 days before trial. Patients must not have had a previous cancer within 3 years prior to this trial. Must not have brain metastasis or have received a transplant. Must not have an active infection, autoimmune disease or allergies to immunotherapy. Patients must not still have any toxicity related to prior cancer treatment, must not have any severe disease such as heart or bowel disease and must not receive any vaccination within 4 weeks before the trial.
How will it work
All patients will receive M7824 over 1 hour on days 1 and 15 by injection. Cycles repeat every 28 days until progression or severe side effects (group A, B, and C) or for six doses in patients with tumor cells in the blood. This will be followed by surgery to liver metastasis (group D).
Patients will be followed up for 2 years for tumor response and survival.