Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers
Status:
Suspended
Trial end date:
2024-07-31
Target enrollment:
Participant gender:
Summary
Background:
Metastatic or refractory/recurrent small bowel and colorectal cancers cannot be cured and are
often not helped by standard treatments. Researchers want to find better treatments by
testing a combination of drugs.
Objective:
To learn if a new combination of immunotherapy drugs can shrink tumors in people with
advanced small bowel and colorectal cancers.
Eligibility:
People ages 18 and older who have advanced metastatic or refractory/recurrent small bowel
and/or colorectal cancer
Design:
Participants will be screened on a separate protocol. They will have a physical exam and
medical history. They will have imaging scans. They will have blood and urine tests. Their
heart function will be measured. They may have a tumor biopsy.
Participants will repeat some of the screening tests during the study.
Participants will be put into study groups. Each group will get a combination of the
following drugs: CV301 vaccine (MVA-BN-CV301 and FPV-CV301), M7824, and N-803. Some will also
get NHS-IL12.
Participants will get the CV301 vaccines by injection under the skin. They will get M7824 by
intravenous infusion every 2 weeks. They will get N-803 by injection under the skin every 2
or 4 weeks. They may get NHS-IL12 by injection under the skin every 4 weeks. They will take
the study drugs for up to 1 year. They will visit the NIH every 2 weeks.
After treatment ends, participants will go to the clinic for a 28-day follow-up visit or have
a telephone call. They will be contacted every 3 months for 1 year, and then every 6 months
after that for the rest of their life.