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The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab

NCT05235737 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-08-31

No results posted yet for this study

Summary

To evaluate the short-term and longer-term safety, tolerability, and effectiveness of neoadjuvant and adjuvant Pembrolizumab on top of standard therapy (Stupp protocol) in patients with Glioblastoma Multiforme (GBM).

Randomized comparison of safety, tolerability, and clinical efficacy of (1) neoadjuvant and adjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), (2) neoadjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), and (3) standard of care (Stupp protocol only, n=12 patients). Immuno-PET examination will be performed before and after surgery in all patients.

Conditions

  • Newly Diagnosed Glioblastoma

Interventions

DRUG

Pembrolizumab

Adding Pembrolizumab as a neoadjuvant and adjuvant therapy to the standard of care protocol

DRUG

Pembrolizumab

Adding Pembrolizumab as a neoadjuvant therapy to the standard of care protocol

Sponsors & Collaborators

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice

    collaborator OTHER

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-06-01
Completion
2026-05-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05235737 on ClinicalTrials.gov