Therapeutic vaccines and an immune checkpoint inhibitor for stage IV colorectal cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drugs, ATP128, VSV-GP128, and BI 754091, are safe and effective for fighting your cancer.

What is the Condition Being Studied?

Colorectal Cancer

Who Can Participate in the Study?

Adults with stage 4 colorectal cancer who:
- Completed at least 6 months of chemotherapy, during which time their tumors shrank or stayed the same size; OR
- Received up to 12 weeks of chemotherapy and have a liver metastasis that is eligible to be removed by surgery

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Get the study drug ATP128 by injection once every 2-to-4 weeks for 4 months
- Get the study drug VSV-GP128 by injection once on day 15
- Get the study drug BI 754091 by I.V. once every 3 weeks for 4.5-to-12 months
- Have surgery to remove your liver metastasis (if applicable)
- Give blood and urine samples
- Have regular CT or MRI scans

Study Details

Full Title
[KISIMA-01] An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer
Principal Investigator
Protocol Number
IRB: PRO00107595
NCT: NCT04046445
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698