This phase 2 trial is examining the effectiveness and safety of durvalumab (Imfinzi) in the treatment of advanced rectal cancer that is not prone to genetic abnormalities. The main outcomes to be measured will be tumor response to the treatment and side effects. This trial is being conducted in the US.
The standard treatment for rectal cancer is surgery and chemotherapy. However, in advanced cases, this is only of limited effectiveness and is often associated with high rates of secondary effects. The addition to the treatment of targeted therapy, such as durvalumab, may improve the treatment outcomes. Durvalumab triggers the immune system to destroy cancer cells. However, the effectiveness and toxicity rates of this drug in advanced rectal cancer are still not clear.
This trial is examining the safety and effectiveness of durvalumab in patients with rectal cancer that have undergone chemo-radiation therapy. The main outcomes will be the response to treatment and side effects.
Who are they looking for?
This trial is recruiting 47 patients with stage 2 to 4 rectal cancer. Patients must have had received a first-line treatment with chemotherapy and radiation therapy (CRT). They should be candidates for surgical removal of the original tumor and should have undergone genetic tests of the tumor. Patients must have adequate blood counts and normal liver and kidney function. Female patients must not be pregnant or breastfeeding and all patients of childbearing potential should agree to use birth control during the study and up to 3 months after the last dose of the study drug.
Patients must not have had previous treatment with other PD-1 antibodies (such as durvalumab), radiation therapy or a live vaccine in the previous 30 days. These patients must not have hepatitis B or C, HIV, brain metastasis, active infections, stomach ulcers, previous organ transplantation, or any other major disease (including heart, brain or lungs).
How will it work
All patients will receive durvalumab infusion every 2 weeks for 4 doses, beginning within 3 to 7 days after CRT. Patients must receive surgery within 8 to 12 weeks of the final dose of radiation therapy. The first 6 patients recruited will be closely followed for 30 days after the last dose of durvalumab. Tissue and blood samples will be collected at follow-up to assess the tumor response to the treatment.