Avelumab in Refractory Testicular Germ Cell Cancer.

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.

Timeline

Start

2017-11-15

Primary completion

2019-02-28

Completion

2019-02-28

Publications

• Background 1) Broun ER et al. Ann Intern Med 1993; 117: 124-8 2) Cierna et al., Ann Oncol, Ann Oncol. 2016 Feb;27(2):300-5. 3) Feldman et al Cancer 2012;118:981-6. 4) Horwich A, et al. Lancet 2006; 367: 754-65 5) Kollmannsberger C et al. Cancer 2006; 106: 1217-26 6) Kondagunta GV et al. J Clin Oncol. 2005 23:6549-55. 7) Mardiak J et al. Neoplasma, 2005; 52: 497-501 8) Fankhauser, C. D et al. Br J Cancer. 2015, 113: 411-413 9) Heery et al. J Clin Oncol 33, 2015 (suppl; abstr 3055) 10) Yamada et al. J Clin Oncol 33, 2015 (suppl; abstr 4047) 11) Disis et al. J Clin Oncol 33, 2015 (suppl; abstr 5509) 12) Gulley et al. J Clin Oncol 33, 2015 (suppl; abstr 8034) 13) Shitara K et al. J Clin Oncol 33, 2015 (suppl; abstr 3023) 14) Kelly K et al. J Clin Oncol 33, 2015 (suppl; abstr 3044) 15) Boyerinas B et al. Cancer Immunol Res. 2015 Oct;3(10):1148-57.

Drugs

Indications