AMP-224, a PD-1 Inhibitor, With Stereotactic Body Radiation Therapy in Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2017-03-07
Target enrollment:
Participant gender:
Summary
Background:
- T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep
T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in
people with cancer. They think the drug might work even better when combined with a certain
type of radiation therapy.
Objective:
- To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic
body radiation therapy (SBRT) directed to the liver.
Eligibility:
- People age 18 and older with metastatic colorectal cancer. Their cancer must have spread to
the liver and not be responding to treatment.
Design:
- Participants will be screened with a medical history, physical exam, and blood and urine
tests. Their tumors will be measured with computerized tomography (CT) scans or magnetic
resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an
electrocardiogram (ECG) heart test.
- Participants will have a small part of their tumor removed by needle (biopsy).
- Participants will have 8 study visits over about 10 weeks.
- At 1 visit, they will have another tumor biopsy.
- At 1 visit, they will get a chemotherapy drug through a vein (intravenous (IV)).
- At 6 visits, they will receive AMP-224 through an IV.
- At 1 or 3 visits, they will have SBRT. Computed tomography (CT) scans will map the
position of their tumor. Radiation beams of different intensities at different angles
will be directed to the tumor.
- At all visits, some screening procedures may be repeated.
- After treatment ends, participants will have 7 follow-up visits over about 5 months.
Blood will be drawn. Some screening procedures may be repeated.