This trial is examining the effectiveness and safety of a combined treatment with pembrolizumab (Keytruda) and binimetinib (Mektovi). The main outcome to be measured is the tumor response to the treatment. This trial is recruiting in the United States and Canada.
Colorectal cancer is the third most common cancer in the US. Chemotherapy is only of limited effectiveness in patients with advanced disease. The addition of immunotherapy agents to the treatment, such as pembrolizumab, increases the effectiveness of the treatment. However, it is not clear how a combined treatment with pembrolizumab and binimetinib affects the treatment of these patients.
This trial is examining the safety and effectiveness of treatment combination containing pembrolizumab and binimetinib in patients with advanced colorectal cancer. The main outcomes evaluated will be response to treatment and side effects.
Who are they looking for?
This trail is recruiting 220 patients with metastatic (spread to other parts of the body) colorectal cancer. Patients must have a life expectancy of at least 3 months and adequate organ function. All patients must agree to use birth control during the study and up to 180 days after the study treatment.
Participants must not have a brain metastasis or brain disease, allergy to the drugs of the trial, active infection, lung disease, immune system disease, HIV, hepatitis. These patients must also not have received a vaccine within 30 days of this trial, or a major surgery. Female participants must not be pregnant or breastfeeding.
How will it work
Patients will be assigned to one of 5 different treatment groups. All groups will receive pembrolizumab. Group A will also receive binimetinib. Group B, will receive mFOLFOX7 (oxaliplatin, leucovorin, 5-fluorouracil) chemotherapy. Group C, will receive mFOLFOX7 and binimetinib. Group D, will receive FOLFIRI (leucovorin, 5-fluorouracil, and irinotecan) chemotherapy. Group E, will receive FOLFIRI and binimetinib.
The main outcomes to be measured are the tumor response to the treatment and treatment side effects. Patients will be followed up for 2 years.