Table 1.
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 | |||||||
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.