Single center, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of neoadjuvant and adjuvant Pembrolizumab on top of standard Chemo-Radiotherapy (Stupp protocol) in Treatment of Patients with newly diagnosed Glioblastoma Multiforme (GBM). (PIRG)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517535-52-00

Acronym

2019/ABM/01/00062

Enrollment

Registered

2024-11-05

Start date

2022-08-24

Completion date

Unknown

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Brief summary

Safety and tolerability – incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated with Pembrolizumab, Patient-Reported Outcomes to evaluate health status and Quality of Life (QoL) instruments for patients with GBM:  Eastern Cooperative Oncology Group (ECOG) status - Karnofsky Performance Status (KPS), - EORTC: QLQ-BN20 (brain), and QLQ-C30 (general cancer questionnaire).

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety and tolerability – incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated with Pembrolizumab, Patient-Reported Outcomes to evaluate health status and Quality of Life (QoL) instruments for patients with GBM:  Eastern Cooperative Oncology Group (ECOG) status - Karnofsky Performance Status (KPS), - EORTC: QLQ-BN20 (brain), and QLQ-C30 (general cancer questionnaire).	—

Measure

Time frame

—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026