This trial is examining the effectiveness and safety of vicriviroc (VIC) plus pembrolizumab (Keytruda) in the treatment of advanced colorectal cancer. The main outcome to be measured is the tumor response to treatment. This trial is being conducted in the US and Canada.
The details
Colorectal cancer is the third most common cancer in the US. The standard treatment for this type of cancer is surgery and chemotherapy. However, chemotherapy has a limited effect in patients with advanced cancers. VIC is a new agent being developed for cancer treatment. Treatment with VIC in combination with pembrolizumab might improve treatment effectiveness.
This trial is evaluating the safety and effectiveness of the combination of VIC and pembrolizumab in patients with advanced colorectal cancer. The main outcomes to be measured are the response to treatment and side effects.
Who are they looking for?
This trial is recruiting 40 participants with advanced colorectal cancer. Patients should have a normal organ activity and male patients should agree in using contraception (condoms). Female patients should not be pregnant or breastfeeding.
Participants should not have a second cancer, have an allergy to the drugs used in this study. Additionally, they should not have an immune system disease, active infection, lung or bowel disease, HIV, Hepatitis B or a mental disorder. Patients should also not have had a surgery prior to the start of this study. Should also not have had a transplant, received prior therapy with VIC, received a vaccine therapy or be involved with another clinical study.
How will it work
All patients will receive VIC and pembrolizumab combination treatment. Patients will be randomly assigned to receive either therapy with VIC low dose or high dose (once daily) combined with pembrolizumab (200 mg, by injection, every 3 weeks for up to 35 weeks).
Tumor response and treatment side effects will be measured during follow-up for up to 2 years.
