Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
Status:
Suspended
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Background:
Immunotherapy drugs help the body to fight cancer. Scientists think that combining some of
these drugs will make them work better than when used alone. This may be true for many types
of cancer, including castration-resistant prostate cancer (CRPC).
Objective:
To test if the combination of the drugs BN-brachyury, M7824, N-803, and Epacadostat is safe
and shrinks tumors.
Eligibility:
People ages 18 and older with CRPC or another metastatic cancer
Design:
Participants will be screened with:
- Medical history
- Physical exam
- CT or MRI scans
- Possible bone imaging
- Blood, urine, and heart tests
- Possible tumor biopsy
Participants will be treated with a 2-, 3- or 4-drug combinations of the following study
drugs in 2-week cycles:
- Participants will receive M7824 by IV once every 2 weeks.
- Participants will receive N-803 by injection once every 2 weeks. They will record any
skin changes at the injection site in a diary.
- Participants will receive BN-brachyury as 4 injections to different limbs. They will get
the first 3 doses 2 weeks apart. Then they will get doses every 4 weeks for 6 months,
then every 3 months for 2 years, then every 6 months.
- Participants will take Epacadostat orally every 12 hours. They will keep a pill diary.
Participants will have physical exams and blood and urine tests at the start of each cycle.
They may have scans every 12 weeks.
Participants will continue treatment until their disease gets worse or they cannot tolerate
the side effects.
Participants will have a follow-up visit 4-5 weeks after they stop treatment. They will have
a physical exam and blood tests. They may be asked to return for scans every 3 months.