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. 2023 May 19;14:1183641. doi: 10.3389/fimmu.2023.1183641

Table 1.

Overview of cohorts in the Glitipni trial.

Cohort Additional
eligibility
criteria
Recruitment
Status
No. of
patients
Study Treatment Recruitment period
Per-operative Post-operative* 2017 2018 2019 2020 2021 2022 2023
1 Resectable Completed 3 MSR iCer 10 mg IPI IV 10 mg NIVO Q2w x6 graphic file with name fimmu-14-1183641-i001.jpg
2 Completed 24 MSR iCer 5 mg IPI + 10 mg NIVO
3 Unresectable Completed 16 STx iTum 5 mg IPI + 10 mg NIVO IV 10 mg NIVO +
iCav 1/5/10 mg NIVO
Q2w x12
4 Resectable Completed 16 MSR iCer 5 mg IPI + 10 mg NIVO
5 Resectable Paused 11 MSR iCer 5 mg IPI + 10 mg NIVO
iCer myDC (1- 10- 20.106)
IV 10 mg NIVO +
iCav 10 mg NIVO
Q2w x12
6 Unresectable Discontinued 2 STx iTum 5 mg IPI + 10 mg NIVO
iTum myDC
7 Resectable Ongoing 27+ MSR iCer 5 mg IPI + 10 mg NIVO IV 10 mg NIVO +
iCav 10 mg NIVO +
iCav 1/5/10 mg IPI
Q2w x12
8 Unresectable Canceled 0 STx iTum 5 mg IPI + 10 mg NIVO
9 Unresectable Discontinued 3 IV 10 mg NIVO +
iThe 10 mg NIVO +
iThe 1/5/10 mg IPI
Q2w x12

In the cohorts following cohort 1 and 2, an Ommaya reservoir was also implanted at the end of the surgery with the catheter hanging freely in the resection cavity, allowing to additionally perform intracavitary injections of nivolumab (cohorts 3 to 6) and the combination of nivolumab and ipilimumab (cohort 7). Cohorts 3, 6, and 8 allowed for the inclusion of patients with unresectable recurrent glioblastoma but with a preexisting resection cavity. Local injection in these patients was performed by stereotactic needle. In cohorts 5 and 6, BDCA1+ and BDCA3+ positive myeloid dendritic cells, obtained through leukapheresis, were injected intracerebrally at the end of the surgery, in addition to ipilimumab and nivolumab. From cohort 3 onwards, cerebrospinal fluid from the peritumoral area is obtained every two weeks, allowing cytological and also pharmacological analysis. MSR, Maximally Safe Resection; STx, stereotactic biopsy; iCer, intracerebral injection; iTum, intraTumoral injection; iCav, intracavitary injection; NIVO, Nivolumab; IPI, Ipilimumab.