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Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma

NCT03665545 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-13

No results posted yet for this study

Summary

Monocentric randomized phase I/II trial, including 24 patients diagnosed with relapsing glioblastoma (GBM) irrespective of MGMT and IDH gene status.

Following diagnosis of relapsing glioblastoma by either brain CT scan or MRI, patients will be randomized in 2 arms:

1. Arm 1: IMA950 mixed with Poly-ICLC administered subcutaneously
2. Arm 2: Pembrolizumab 200mg q3w IV and IMA950 mixed with Poly-ICLC administered subcutaneously

The first phase of treatment will last 6 weeks, then surgery will be performed (done if clinically possible ad indicated). In case of available brain tissue, extensive analysis of the tumor immune response will be performed. Assessment of systemic immune response by PBMC immunomonitoring will be systematically done before and after surgery.

Conditions

Interventions

DRUG

IMA950/Poly-ICLC

IMA950 mixed with Poly-ICLC administered subcutaneously

DRUG

IMA950/Poly-ICLC and pembrolizumab

IMA950 mixed with Poly-ICLC administered subcutaneously in combination with pembrolizumab

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Nicolas Mach, Prof. · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2023-12-31
Completion
2024-04-24

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT03665545 on ClinicalTrials.gov