VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)

Background:
Gastrointestinal cancer is one of the most common cancers worldwide. Researchers think an unmet need exists to understand and improve treatment options. They want to see if a combination of drugs can help people with metastatic colorectal cancer.
Objective:
To see if using a combination of Vascular Biogenics (VB)-111 and nivolumab is safe and will cause colorectal tumors to shrink.
Eligibility:
People ages 18 and older with microsatellite stable colorectal cancer that has spread to the liver
Design:
Participants must consent to sample collection protocol 11C0112.
Participants will be screened with:
Blood tests
Scans
Tumor samples. If these are not available, participants will have a biopsy.
Before they start treatment and with every treatment cycle, participants will have:
Physical exams
Blood tests
Heart tests
Before they start treatment and every 4 cycles, participants will have computed tomography (CT) or magnetic resonance imaging (MRI) scans. For these, they will lie in a machine that takes pictures of the body. For the MRI, a soft padding or coil will be placed around their head.
Participants will have biopsies before they start therapy. They will have them again after 2 6 weeks on study.
On day 1 of 14-day cycles, participants will get one or both study drugs by vein.
After they finish treatment, participants will have monthly visits for 3 months. They will have a physical exam and blood tests.
If participants stop treatment for reasons other than their disease getting worse, they will have scans about every 8 weeks. This will continue until their disease gets worse.
Participants will be contacted by phone or email every 6 months. This will continue for life.
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