Baseline characteristics
| Characteristic | Total (N=133)* |
| Age, years, median (range) | 65 (21–88) |
| Race, n (%) | |
| White | 118 (88.7) |
| Black | 9 (6.8) |
| Other | 4 (3.0) |
| Asian | 1 (0.8) |
| American Indian/Alaskan native | 1 (0.8) |
| ECOG performance status, n (%) | |
| 0 | 41 (30.8) |
| 1 | 91 (68.4) |
| 2 | 1 (0.8) |
| No. of prior therapies, median (range) | |
| All patients (N=133) | 2 (0–6) |
| NSCLC anti-PD-1/PD-L1–naïve† (n=14) | 1 (0–5) |
| NSCLC prior anti-PD-1/PD-L1† (n=21) | 2 (0–4) |
| HNSCC anti-PD-1/PD-L1–naïve† (n=18) | 1 (0–3) |
| HNSCC prior anti-PD-1/PD-L1† (n=19) | 3 (0–5) |
| Urothelial cancer† (n=17) | 2 (0–4) |
| Cutaneous melanoma† (n=13) | 3 (0–6) |
| NSCLC PD-1/PD-L1–naïve cohort, n | 14 |
| Histological subtype, n (%)‡ | |
| Squamous | 7 (50) |
| Non-squamous | 7 (50) |
| Prior TKI, n (%)‡ | 1 (7) |
*Of the 133 patients enrolled and treated, 12 were in the escalation phase and 121 in the expansion phase. Overall, there were 16 patients treated in the NSCLC anti-PD-1/PD-L1–naïve cohort, 25 in the NSCLC prior anti-PD-1/PD-L1 cohort, 21 in the HNSCC anti-PD-1/PD-L1–naïve cohort, 24 in the HNSCC prior anti-PD-1/PD-L1 cohort, 21 in the urothelial cancer cohort, 14 in the cutaneous melanoma cohort, and 12 patients with other tumor types.
†Response-evaluable patients. There was a total of 19 patients not evaluable for response, with 2 in the NSCLC anti-PD-1/PD-L1–naïve cohort, 4 in the NSCLC prior anti-PD-1/PD-L1 cohort, 3 in the HNSCC anti-PD-1/PD-L1–naïve cohort, 5 in the HNSCC prior anti-PD-1/PD-L1 cohort, 4 in the urothelial cancer cohort, and 1 in the cutaneous melanoma cohort.
‡Percentages are calculated over 14 total NSCLC PD-1/PD-L1–naïve patients.
ECOG, Eastern Cooperative Oncology Group; HNSCC, head and neck squamous cell carcinoma; NSCLC, non–small cell lung cancer; PD-1, programmed cell death-1; PD-L1, programmed death-ligand 1; TKI, tyrosine kinase inhibitor.