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Report for Clinical Trial NCT03899857

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pembrolizumab for Newly Diagnosed Glioblastoma: a Prospective, Open-label, Single-arm, Multicenter Phase II Study

The study explores the addition of pembrolizumab to temozolomide-based radiotherapy in patients with newly diagnosed glioblastoma.

NCT03899857 Newly Diagnosed Glioblastoma
MeSH:Glioblastoma
HPO:Glioblastoma multiforme

1 Interventions

Name: Pembrolizumab

Description: Pembrolizumab will be added to standard of care
Type: Drug
Group Labels: 1

Pembrolizumab


Primary Outcomes

Description: To explore whether the addition of pembrolizumab to standard temozolomide-based radiochemotherapy improves the outcome of newly diagnosed glioblastoma or gliosarcoma patients, determined by the overall survival rate at 12 months

Measure: Overall survival at 12 months

Time: At 12 months

Secondary Outcomes

Measure: Response rates using (i)RANO (immunotherapy response assessment in neuro-oncology) criteria

Time: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

Measure: Progression-free survival (PFS) at 6 and 12 months

Time: At 6 and 12 months

Measure: Time to treatment failure (TTF)

Time: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

Description: HRQoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) version 3. Scoring: 0 to 100. Higher scores mean a better level of functioning.

Measure: Health-related Quality of life (HRQol)

Time: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

Description: Expression levels of PD-L1 will be determined in the tumor tissue and correlated with response as determined by MRI and progression-free as well as overall survival

Measure: Correlation of programmed cell death (PD-1) ligand 1 (PD-L1) expression levels with response to treatment and outcome

Time: From the inclusion in the study until the end of follow-up (up to approximately 36 months)

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 R132H

- Newly diagnosed glioblastoma or gliosarcoma as confirmed by local histopathology - The patient is at least 18 years of age on day of signing informed consent - Absence of isocitrate dehydrogenase (IDH)1 R132H mutation by immunohistochemistry - A maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreased for ≥5 days prior to start of radiotherapy - Patient who are treated with anticoagulants are on a stable dose for at least two weeks prior to start of radiotherapy (RT) - The patient is male or a non-pregnant, non-lactating female - Females of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test within 2 weeks prior to receiving the first dose of study medication. --- R132H ---



HPO Nodes


HPO: