This phase 1/2 trial is examining the effectiveness of standard therapy alone or combined with new drugs as first line treatment for advanced colorectal cancer. The main outcome to be measured will be safety and tumor response to the treatment.
Colorectal cancer is one of the most common cancers worldwide. A significant number of patients present with metastatic (spread to other parts of the body) disease. Chemotherapy and radiation therapy used to be the standard care. Chemotherapy includes regimens with multiple drugs such as FOLFOX (oxaliplatin, leucovorin, fluorouracil).
However, these therapies are only of limited effectiveness for these patients. Therefore, other drugs started to be introduced in the therapy. Immunotherapy such as bevacizumab (Avastin) is a type of newer therapy. These agents help the immune system to find and kill cancer cells improving the anti-tumor effect of the treatment. Other new agents are durvalumab (Imfinzi) and oleclumab (MEDI9447).
This trial is examining the safety and effectiveness of standard of care (FOLFOX + bevacizumab) alone or combined with durvalumab and oleclumab in the treatment of advanced colorectal cancer. The main outcomes will be measured as the number of side effects associated to the treatment and the change in tumor size.
Who are they looking for?
This trial is recruiting 112 participants with colorectal cancer and at least one metastasis. These patients must have normal organ function and body weight above 35 kg. Patients of childbearing potential must agree to use adequate birth control.
Participants must not have had a transplant, autoimmune disorders, heart disease, bowel disease or any other cancer. Must not have an active infection, allergy to the drugs of the study, brain metastasis. Participants must not have had prior immunotherapy, a live vaccine 30 days prior to this trial or a major surgery within the past 28 days. Female patients must not be pregnant or breastfeeding.
How will it work
Participants will be assigned to two different groups. In the standard therapy group, patients will receive FOLFOX plus bevacizumab on day 1 and 2 of every 14-day cycle. Patients on the second group will receive the standard therapy (as group 1) plus durvalumab and oleclumab.
Patients will be followed for side effects, response to treatment, and survival for up to 5 years.