Clinical Trial: Immunotherapy Combination for Advanced Small Bowel and Colorectal Cancer

Metastatic or Recurrent Small Bowel and Colorectal Cancer cannot be completely treated or managed by standard treatment methods and therapies. To overcome this obstacle, the researchers want to discover and introduce its cure by testing a combination of immunotherapy drugs. The Phase II Trial is being conducted at the NIH Clinical Center (National Institutes of Health Clinical Center). 

Objective: To study the clinical relevance of a new combination of immunotherapy drugs and inspect if they can shrink tumors in subjects with Advanced Small Bowel and Colorectal Cancers. 

Eligibility: Subjects aged 18 years and above who are diagnosed with advanced metastatic or recurrent small bowel or/and colorectal cancer. 

Plan: The participants (individuals who will take part in this clinical trial) will be screened on a predefined protocol. They will be going through a physical exam. Their medical history will be collected. Those individuals will also have imaging scans accompanied by blood and urine tests. After these tests, their heart function will be studied. The participants might also have a tumor biopsy. During the study, the participants will be asked to repeat a number of screening tests.

They will be put into different groups known as study groups. The participants of each group will receive a combination of drugs:

• CV301: It is given as an injection under the skin. It works to target certain proteins expressed by tumors. 

• M7824: It is given intravenously as an infusion every 2 weeks. It works to block pathways used by cancer cells to hinder attacks by the immune system.

• N-803: It is given as an injection under the skin every 2 or 4 weeks. It works to improve the ability of the immune system to kill cancer cells in the body. 

Some patients will also receive NHS-IL12 every 4 weeks as an injection under the skin. It works by triggering the immune system to fight against the cancer cells in the body. The patients will receive these study drugs for about a year. The patients will also visit NIH Clinical Center every 2 weeks. Once the treatment ends, they will be asked to go to the clinic for either a follow-up visit (28 days) or a telephone call. The patients will be approached (periodically) once in 3 months for a year and then once in 6 months for the rest of their life. 

Colorectal Cancer is the second growing cause of the increasing mortality rate, with an estimated 8.3% of total annual cancer-related deaths and on average 140,250 new cases of Colorectal Cancer diagnosed in the past year. Although overall mortality from this cancer has started to decline, survival of the patients still remains poor for advanced stages. This provides evidence of the growing need for a better treatment option for patients with Metastatic or Recurrent Small Bowel and Colorectal Cancer. 

Through this clinical trial, the researchers want to inspect if this immunotherapy combination is a better treatment for Metastatic or Recurrent Small Bowel and Colorectal Cancer or not.