A Study of the Safety and Antitumoral Efficacy of Nivolumab After SIRT for the Treatment of Patients With HCC
Status:
Completed
Trial end date:
2020-11-04
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effect of the anti-programmed death 1 (PD-1)
agent nivolumab following selective internal radiation therapy (SIRT) for patients with
unresectable hepatocellular carcinoma (HCC).
SIRT using yttrium90-loaded microspheres is increasingly used to treat patients with HCC,
particularly those that are not good candidates for transarterial chemoembolization or TACE.
SIRT induces disease control (objective tumor remission or stabilization) in most patients
while progression usually results from the growth of new lesions. SIR-Spheres are resin-made
microspheres used for SIRT.
On the other hand, nivolumab is under clinical development for the treatment of more advanced
HCC. Available data in patients that mostly had progression to other therapies and vascular
involvement or metastatic disease show significant systemic antitumor activity that results
in durable objective remissions and disease stabilizations.
Therefore, in patients with HCC that has not spread beyond the liver, the systemic action of
nivolumab may improve the anti-tumor effect of SIRT. Furthermore, by inducing immunogenic
tumor cell death, SIRT may have a synergistic effect with nivolumab.
Phase:
Phase 2
Details
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra