Table 1

Clinical characteristics and numbers in correlative study elements (n=24)

Age (years)
Median (IQR)64.0 (58.0 to 69.5)
Number of previous treatments (n, %)
 11 (4%)
 28 (33%)
 ≥315 (63%)
 Median (range)4.5 (1 to 13)
Platinum sensitivity* (n, %)
 Platinum-sensitive5 (21%)
 Platinum-resistant18 (75%)
 Platinum-refractory1 (4%)
Best RECIST response (n, %)
 PR8 (33%)
 SD ≥6 months6 (25%)
 Total CBR (PR+SD ≥6 months)14 (58%)
 SD <6 months3 (13%)
 PD7 (29%)
Correlative studies (n, %)
 Tumor biopsies
  Pre-treatment18 (75%)†
  Post-treatment12 (50%)†
  Paired9 (38%)
Flow cytometry23 (96%)‡
Immunohistochemistry21 (88%)§
CBC24 (100%)
  • *Platinum-sensitive: recurs 6 or more months after cessation of last platinum-based chemotherapy; platinum-resistant: progression within 6 months of last platinum-based therapy; platinum-refractory: progression while actively on platinum-based therapy.

  • †All 24 patients had baseline biopsies performed, however six were determined to be non-tumor tissue by RNAseq analysis and were excluded from analysis.Thirteen patients had an optional second biopsy performed, and one was determined to be of non-tumor origin and excluded.

  • ‡C1D15 PBMCs from one patient were missing.

  • §Archival tissue from one patient was exhausted prior to enrollment in the trial and was unevaluable in two patients due tissue fragmentation and lack of stroma.

  • CBC, complete blood count; CBR, clinical benefit rate; PBMC, peripheral blood mononuclear cells; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors ; RNAseq, RNA sequencing; SD, stable disease.