The aim of this phase 2 trial is to compare the effectiveness of the combined treatment with chemotherapy, avelumab (Bavencio) and the vaccine Ad-CEA in patients with metastatic (spread to other parts of the body) colorectal cancer. The main outcome to be measured is tumor response to the treatment. This trial will recruit in Maryland, United States.
The details
The standard treatment for colorectal cancer is chemotherapy. Anti-PD-1 therapy such as avelumab and vaccines such as Ad-CEA helps the immune system to fight tumor cells. Therefore the addition of these drugs to chemotherapy may improve the tumor response.
The current trial will investigate whether the combination treatment is more effective than chemotherapy alone. The main outcome will be measured through rates of tumor progression.
Who are they looking for?
The trial will recruit 81 participants with metastatic colorectal cancer. Patients must have normal blood levels and should have inoperable metastases. Patients must not have HIV, hepatitis or any other severe active disease such immune diseases, heart conditions, bowel or lung disease. Patients should not have brain metastasis. Women should not be pregnant or breastfeeding. Men and women must agree to use contraception during the trial and for 4-6 months afterwards.
How will it work
Patients will be randomly assigned to receive treatment with chemotherapy, avelumab and Ad-CEA or chemotherapy alone. Patients from the chemotherapy alone group will receive 6 to 12 two-week cycles of bevacizumab (Avastin; over 30-90 minutes by injection on day 1) and the chemotherapy FOLFOX. This will be followed by two-week cycles of bevacizumab and capecitabine (capsules every day) until disease progression. Patients in the combination group will be treated with FOLFOX and bevacizumab, along with avelumab and Ad-CEA on weeks 0, 2, 4, 8, 12, 16, and then every 12 weeks for up to 12 cycles. This will be followed by bevacizumab, capecitabine, avelumab, and Ad-CEA until disease progression.
Patients will be followed for up to 18 months to determine time until disease progression.
