This phase 2 trial is investigating the effectiveness of a treatment combination to treat metastatic (spread to other parts of the body) colorectal cancer that has not responded to prior therapy. The main outcome to be measured is response to treatment on imaging. This trial is taking place in Colorado, United States.
The details
Colorectal cancer is the third most common cancer in the US. Chemotherapy and radiation therapy are the standard treatment. Prior studies showed that immunotherapy is associated with improved cancer responses. A combined treatment with different immunotherapy drugs may give an extra benefit to patients who did not respond to prior treatment.
This trial is measuring the effectiveness of a combined treatment consisting of pembrolizumab (Keytruda), binimetinib (Mektovi) and bevacizumab (Avastin). Tumor response will be measured as well as survival and side effects of the treatment.
Who are they looking for?
This study is looking for 40 participants with unresponsive advanced colorectal. Patients must have normal blood and organ function. Female patients of childbearing age must agree to refrain from sexual intercourse or use contraceptive methods during the study and up to 180 days after the last dose. Male patients with female partners of childbearing age must use contraception or refrain from sexual intercourse or from donating sperm during the study and up to 180 days after the last dose.
Patients must not be pregnant or breastfeeding. They must not have a BRAF mutation (permanent change) in their tumor. To be included, patients also must not have brain metastasis, allergies to immunotherapy drugs or autoimmune diseases. Patients must not have any heart or lung disease or any active infection.
How will it work
This study will be done in two stages. In stage 1, 10 patients will be treated with the standard doses of pembrolizumab, binimetinib and bevacizumab to test for treatment side-effects.
In stage 2, patients will be separated into 2 groups. The first group will receive binimetinib for 7 days followed by pembrolizumab, bevacizumab, and binimetinib in 21 days cycles. The second group will receive only pembrolizumab, bevacizumab, and binimetinib, without the first treatment with binimetinib for 7 days.
Response to treatment, the time until the tumor grows or spreads and overall survival will be measured after 12 months and up to 100 weeks.
