Arndt Vogel, MD, discusses the trial design of IMMUTACE, which is evaluating the efficacy of transarterial chemoembolization in combination with nivolumab for the treatment of intermediate-stage hepatocellular carcinoma.
Arndt Vogel, MD, the managing senior consultant and professor in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, discusses the trial design of IMMUTACE (NCT03572582), which is evaluating the efficacy of transarterial chemoembolization (TACE) in combination with nivolumab (Opdivo) for the treatment of intermediate-stage hepatocellular carcinoma (HCC).
According to Vogel, the trial enrolled 50 patients with intermediate-stage HCC. During the study, patients received their first TRACE. After 2 or 3 days, nivolumab was started and patients were allowed to receive a second TRACE. At the time of first progression, patients were allowed to receive a second local therapy and continue with nivolumab.
After the second progression, the treatment was regarded as a failure. The primary end point was overall response rate, which was reached in more than 55% of patients.
0:08 | We looked at 50 patients with intermediate stage HCC. It was a single arm study. patients received to first TACE. Then after 2 or 3 days, nivolumab was started. Patients were allowed to receive a second TACE. And then nivolumab was continued. One patient had progressive disease. This was the time point where we determined the first progression. Patients were then allowed to get another local therapy if it was feasible, and patients then could continue with nivolumab. After the second progression, failure strategy was reached. This was a secondary end point which we have not yet reported. The primary endpoint was overall response rate. We saw a response rate of more than 55% as a positive segment.