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Table 1 Clinical characteristics of patients enrolled in the dose escalation cohort of the PEMBIB phase 1b trial

From: Safety, recommended dose, efficacy and immune correlates for nintedanib in combination with pembrolizumab in patients with advanced cancers

 

DL1

Nintedanib

150 mg bid

N = 6

DL2

Nintedanib

200 mg bid

N = 6

Total

N = 12

Sex

 Male

3 (50%)

3 (50%)

6 (50%)

 Female

3 (50%)

3 (50%)

6 (50%)

 Age, Median (range)

62 (43–74)

49 (40–67)

59 (40–74)

ECOG PS

 0

3 (50%)

4 (67%)

7 (58%)

 1

3 (50%)

2 (33%)

5 (42%)

 Breast cancer

0

1 (17%)

1 (8%)

 Cervical cancer

2 (33%)

0

2 (17%)

 Colorectal carcinoma dMMR

1 (17%)

0

1 (8%)

 Gastric carcinoma

1 (17%)

0

1 (8%)

 Renal clear cell carcinoma

1 (17%)

0

1 (8%)

 Caecal neuroendocrine carcinoma

0

1 (17%)

1 (8%)

 Peritoneal mesothelioma

0

1 (17%)

1 (8%)

 Pleural mesothelioma

0

1 (17%)

1 (8%)

 Thymic carcinoma

0

2 (33%)

2 (17%)

 Nasopharyngeal undifferenciated carcinoma

1 (17%)

0

1 (8%)

 Median previous lines of treatment

2 (1–5)

1.5 (1–2)

2 (1–5)

Lung Immune Prognostic Index (LIPI)

 Good

6 (100%)

2 (33%)

8 (67%)

 Intermediate

0

4 (67%)

4 (33%)

 Poor

0

0

0

GRIm-score

 0–1

6 (100%)

3 (50%)

9 (75%)

 2–3

0

3 (50%)

3 (25%)

 Median Neutrophil (.103/mm3) (range)

4.45 (3.6–6.1)

3.75 (2–5.4)

4.2 (2.5–6.1)

 Median Lymphocytes (.103/mm3) (range)

1.4 (1.2–3.2)

1.1 (0.6–1.4)

1.2 (0.6–3.2)

 Median Albumin (g/L) (range)

40 (36–44)

42.5 (35–50)

40.5 (35–50)

 Median LDH UI/L (range)

186 (147–245)

288 (154–550)

208 (147–550)

 Median CRP (mg/L) (range)

11.1 (5.9–68.2)

17.3 (4.9–49.8)

11.1 (4.9–68.2)

  1. Abbreviations: DL Dose Level, ECOG PS Eastern Cooperative Oncology Group Performance Status, dMMR mismatch repair deficient, LIPI Lung Immune Prognostic Index [23], GRIm-score Gustave Roussy Immune Score [24]