A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

Trial ID #	NCT01375842
Phase	I
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-L1
Drug Name	Atezolizumab
Alternate Drug Names	Tecentriq, Anti-PD-L1 Monoclonal Antibody MPDL3280A , MPDL3280A, RG7446
Drugs in Trial	Atezolizumab
Eligible Participant	Metastatic or Locally Advanced Solid Tumors
Patients Enrolled	661 (12 ovarian)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DoR, PFS, OS, evaluated per RECIST
Biomarkers	Exploratory: PD-L1 protein
Efficacy	ORR: 22% (1CR, 1PR, n=9) HGSOC, 1 PD-L1 IC3 mixed endometrioid/clear cell DoR: 8.3 months and 30.6+ months PFS: 2.9 months OS: 11.3 months Exploratory analysis PD-L1 levels: Responders (1 HGSOC, 1 mixed endometrioid/clear cell) were PD-L1 IC2/3 (PD-L1+) and had low CA125 baseline levels.
Clinically Significant Adverse Events	Serious AE: grade 2 pyrexia (8.3%) Grade 3-4 AE: autoimmune hepatitis (8.3%), maculopapular rash (8.3%)
Conclusion	Encouraging activity with acceptable safety profile
Reference	Liu JF et al. Safety, clinical activity and biomarker assessments of atezolizumab from a Phase I study in advanced/recurrent ovarian and uterine cancers. Gynecol Oncol (2019) 154(2):314-322. https://www.ncbi.nlm.nih.gov/pubmed/31204078