Overview

Avelumab in Refractory Testicular Germ Cell Cancer.

Status:
Completed
Trial end date:
2019-02-28
Target enrollment:
Participant gender:
Summary
This is a proof-of-concept study to define efficacy of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs). Data suggest that PD-L1 is overexpressed in TGCTs, and PD-L1 expression is significantly higher in GCTs in comparison to normal testicular tissue.Patients with low PD-L1 expression had significantly better progression-free survival (hazard ratio [HR] = 0.40, 95% CI (0.16 - 1.01, p = 0.008) and overall survival (HR = 0.43, 95% CI (0.15 - 1.23, p = 0.040) compared to patients with high PD-L1 expression. These data suggest that PD-1/PD-L1 pathway could be a novel therapeutic target in TGCTs and that there is strong rationale to inhibit PD-1/PD-L1 signaling in GCTs.
Phase:
Phase 2
Details
Lead Sponsor:
National Cancer Institute, Slovakia
Collaborators:
Merck KGaA
Merck KGaA, Darmstadt, Germany
Treatments:
Antibodies, Monoclonal
Avelumab