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-1
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) Jan 24
https://www.ncbi.nlm.nih.gov/pubmed/30676622