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

What is the Purpose of this Study?

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
What is the Condition Being Studied?
Colorectal Cancer

Who Can Participate in this 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
Participating Institutions

What is Involved?

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.

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

Contacts
Protocol Number
IRB:
PRO00107595

NCT:
NCT04046445
ClinicalTrials.gov
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