Table 4 Summary of safety

From: Neoadjuvant immune checkpoint blockade before chemoradiation for cervical squamous carcinoma (GINECO window-of-opportunity COLIBRI study): a phase II trial

AE, No. (%)

Neoadjuvant ipilimumab/nivolumab (n = 40)

Chemoradiation (n = 40)

Maintenance nivolumab (n = 39)

Any AE

33 (83)

38 (95)

35 (90)

 Any treatment-related AE

26 (65)

38 (95)

29 (74)

  Nivolumab

25 (63)

18 (45)

20 (51)

  Ipilimumab

25 (63)

17 (43)

5 (13)

  Chemoradiation

NA

37 (93)

14 (36)

Any grade ≥2 AE

14 (35)

33 (83)

17 (44)

 Any treatment-related grade ≥2 AE

7 (18)

30 (75)

14 (36)

  Nivolumab/ipilimumab

7 (18)

13 (33)

11 (28)

  Chemoradiation

NA

27 (68)

7 (18)

Any grade ≥3 AE

4 (10)

12 (30)

7 (18)

 Any treatment-related grade 3/4 AE

1 (3)

11 (28)

7 (18)

  Nivolumab

1 (3)a

3 (8)b

5 (13)c

  Ipilimumab

1 (3)a

3 (8)b

1 (3)c

  Chemoradiation

NA

10 (25)

4 (10)

  1. AE adverse event, ALT alanine aminotransferase, NA not applicable.
  2. aOne case of grade 3 asthenia.
  3. bOne case of grade 3 asthenia (considered related to nivolumab and ipilimumab) and two cases of grade 3 lymphopenia (considered related to nivolumab, ipilimumab, and chemoradiation).
  4. cOne case each of grade 3 musculoskeletal pain, grade 3 rash, grade 3 increased ALT, and grade 3 lymphopenia/grade 3 asthenia considered related to nivolumab, and one case of grade 3 radiation proctitis considered related to nivolumab, ipilimumab, and chemoradiation.
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