This phase 2 trial is examining the effectiveness and safety of navarixin (MK-7123) in combination with pembrolizumab (Keytruda) in patients with colorectal cancer (CRC). The main outcome to be measured will be the objective response rate (ORR; tumor shrinkage or disappearance).
A treatment option for patients with metastatic (cancer cells spread from original place to a distant part of the body) and advanced solid tumors is with pembrolizumab. This is a type of lab-made antibody which marks cancer cells to be destroyed by our immune system. An alternative is to combine pembrolizumab with other medications such as navarixin. This drug works to reduce inflammation in the body. It is not known if navarixin and pembrolizumab combination therapy is more effective and safe at treating advanced solid tumors.
This study is being done to investigate the effectiveness and safety of navarixin in combination with pembrolizumab in patients with advanced CRC. The main outcome to be measured will be the ORR after a 2-year follow-up.
Who are they looking for?
120 participants with advanced or unresectable (not suitable for surgery) CRC and other solid tumors will be recruited. Patients must have a biopsy to confirm advanced solid tumors, and have adequate organ function. Women must have a negative pregnancy test and be on adequate contraception throughout the trial. Participants must have progressed on prior treatment options, including fluoropyrimidine, oxaliplatin, and irinotecan.
Patients cannot participate if they have a different cancer that is worsening. They must not have metastases to the brain, spinal cord or be allergic to the treatment. Participants must not have an autoimmune disease, active infection, HIV, hepatitis B or C or a gastrointestinal condition. They must not have had recent surgery or radiotherapy. Women not on contraception, who are pregnant or breastfeeding cannot take part. Participants must not have had a live-virus vaccine in the previous 30 days.
How will it work
There will be two groups. Group 1 will receive navarixin once a day by mouth at a certain dose and pembrolizumab once a day by intravenous (IV) injection for up to 2 years. Group 2 will receive navarixin at a different dose along with the same dose of pembrolizumab.
Patients will be followed up for 2 years for response to treatment and side effects.