Table 1

Patients and disease baseline characteristics according to the randomly allocated treatment arm

Arm A
avelumab
N=30
Arm B
avelumab+cetuximab
N=30
Median age (range), years65 (35–84)63 (39–77)
Race, n (%)
Caucasian29 (97)30 (100)
Asian1 (3)0 (0)
Sex, n (%)
Female24 (80)17 (57)
Male6 (20)13 (43)
ECOG performance status, n (%)
016 (53)18 (60)
112 (40)11 (37)
22 (7)1 (3)
HIV status
Positive3 (10)1 (3)
Negative27 (90)29 (97)
HPV status
Positive25 (89)26 (93)
Negative3 (11)2 (7)
Not evaluable22
Disease stage at diagnosis, n (%)
I–III18 (60)18 (60)
IV12 (40)12 (40)
Metastatic sites at diagnosis, n (%)
15 (17)4 (13)
22 (7)2 (7)
≥35 (17)6 (20)
Burden of disease at the enrolment, n (%)
Local relapse/persistent disease only8 (27)3 (10)
Distant metastases22 (73)27 (90)
Previous lines of systemic treatment, n (%)
09 (30)6 (20)
114 (47)14 (47)
≥27 (23)10 (33)
  • ECOG, Eastern Cooperative Oncology Group.