Phase I clinical trial on intra-tumoral ipilimumab plus intravenous nivolumab following the resection of recurrent glioblastoma

Conditions

glioblastoma

Brief summary

incidence of treatment related severe adverse events; determined for each dose level of ipilimumab

Detailed description

Anti-tumor activity: objective response rate (ORR); according to the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria. When iRANO criteria are not applicable due to resection and/or not evaluable disease, time of diagnosis of tumor recurrence/progression will be established at the discretion of the treating investigator., Progression-free survival (PFS): by iRANO criteria. When iRANO are not applicable due to resection and/or not evaluable disease, time of diagnosis of tumor recurrence/progression will be established at the discretion of the treating investigator., Overall survival (OS): defined as the time from neurosurgery to death.

Related papers

No related papers found yet.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGAutologous CD1c(BDCA-1)+/CD141(BDCA-3)+ myDC cell product

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
incidence of treatment related severe adverse events; determined for each dose level of ipilimumab	—

Secondary

Measure	Time frame
Anti-tumor activity: objective response rate (ORR); according to the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria. When iRANO criteria are not applicable due to resection and/or not evaluable disease, time of diagnosis of tumor recurrence/progression will be established at the discretion of the treating investigator., Progression-free survival (PFS): by iRANO criteria. When iRANO are not applicable due to resection and/or not evaluable disease, time of diagnosis of tumor recurrence/progression will be established at the discretion of the treating investigator., Overall survival (OS): defined as the time from neurosurgery to death.	—

Measure

Time frame

Anti-tumor activity: objective response rate (ORR); according to the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria. When iRANO criteria are not applicable due to resection and/or not evaluable disease, time of diagnosis of tumor recurrence/progression will be established at the discretion of the treating investigator., Progression-free survival (PFS): by iRANO criteria. When iRANO are not applicable due to resection and/or not evaluable disease, time of diagnosis of tumor recurrence/progression will be established at the discretion of the treating investigator., Overall survival (OS): defined as the time from neurosurgery to death.

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Countries

Belgium

Outcome results

None listed