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Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer

Liver Metastases Clinical Trial

Official title:
Combination Treatment of Nivolumab, Ipilimumab, Intratumoral CMP-001 and Radiosurgery for Liver Metastases in Colorectal Carcinoma

Clinical Trial Summary

A single institution study to evaluate the safety and tolerability of the combination treatment of nivolumab, ipilimumab, CMP-001 and radiosurgery in patients with metastatic colorectal cancer with liver metastases.

Clinical Trial Description

Patients will be treated with radiosurgery to liver metastases (completed by day 1), followed by a priming dose of subcutaneous CMP-001 (day 1 ± 4 days), intratumoral injections of CMP-001 on days 13, 36 and 55, combined with nivolumab 3mg/kg every 2 weeks (start day 15) and ipilimumab 1 mg/kg every 6 weeks (start day 15). From day 71 biweekly subcutaneous injections of CMP-001 will commence. Nivolumab, ipilimumab and subcutaneous injections of CMP-001 will be continued until disease progression or up to 24 months in the absence of disease progression or unacceptable toxicity. Two research biopsies will be taken from a liver metastasis. The first biopsy will be taken during the screening period (pretreatment) and the second one 5 weeks post-radiosurgery (which is 3 weeks post-initiation of nivolumab / ipilimumab). As a safety run-in, the initial cohort of 3-6 patients will not receive radiosurgery. The next cohort will not commence until the last patient from the initial cohort has been followed up for at least 8 weeks post first intratumoral injection. Efficacy endpoints will be based upon a non-irradiated lesion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03507699
Study type Interventional
Source Sheba Medical Center
Contact
Status Completed
Phase Phase 1
Start date December 15, 2018
Completion date May 25, 2022
View Details
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