A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Trial ID #	NCT01772004
Phase	I
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-L1
Drug Name	Avelumab
Alternate Drug Names	Anti programmed death ligand 1 monoclonal antibody, Anti-PD-L1, MSB0010718C, Bavencio
Drugs in Trial	Avelumab
Eligible Participant	Metastatic or Locally Advanced Solid Tumors
Patients Enrolled	1670 [125 ovarian; median 3 prior therapies (1-10)]
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, OS, evaluated per RECIST
Biomarkers	Exploratory: BRCA1/2, PD-L1 protein
Efficacy	ORR: 9.6% (1CR, 11PR, n=125) DCR: 52.0% (1CR, 11PR, 53SD, n=125) PFS: 2.6 months (1.4-2.8) DoR: 10.4 months (4.2-NA) OS: 11.2 months (8.7-15.4) Exploratory analysis: PD-L1 levels, BRCA status): No disease related parameter was associated with response to Ave
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: 7.2% (9/125)
Conclusion	Encouraging activity with acceptable safety profile
Reference	Disis, ML et al. Efficacy and Safety of Avelumab for Patients With Recurrent or Refractory Ovarian Cancer: Phase 1b Results From the JAVELIN Solid Tumor Trial. Jama Oncol (2019) 5(3):393-401 https://www.ncbi.nlm.nih.gov/pubmed/30676622