Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)

Phase 1

• Conditions: Oncology - Glioblastoma (GBM); MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002250-24-FR
• Lead Sponsor: Global Coalition for Adaptive Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

Main Inclusion Criteria - Newly Diagnosed:
• Age = 18 years.
• Histologically confirmed Grade IV GBM/gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy.
• - An MRI scan performed within 21 days prior to randomization preferably.
• Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
• Karnofsky performance status = 60% performed within a 14-day window
prior to randomization.
• Availability of tumor tissue representative of GBM from definitive surgery or biopsy.

Main Inclusion Criteria - Recurrent:
• Age = 18 years.
• Histologically confirmed GBM/gliosarcoma (WHO criteria; non-IDH R132H mutant) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum Radiation Therapy (RT).
• Evidence of recurrent disease (RD) demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
• Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
• Baseline MRI performed within 14 days prior to randomization.
• Karnofsky performance status = 70% performed within a 14-day window
prior to randomization.
• Availability of tumor tissue representative of GBM from initial definitive
surgery and/or, recurrent surgery, if performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 277
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

Main Exclusion Criteria - Newly Diagnosed:
• Any prior treatment for glioma including: prior prolifeprospan 20 with
carmustine wafer; prior intracerebral agent; prior radiation treatment for
GBM or lower-grade glioma; prior chemotherapy or immunotherapy for
GBM or lower-grade glioma.
• Receiving additional, concurrent, active therapy for GBM outside of the trial
• Extensive leptomeningeal disease.
• QTc > 450 msec if male and QTc > 470 msec if female.
• History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
• Laboratory results that meet exclusionary parameters.

Main Exclusion Criteria - Recurrent Exclusion Criteria:
• Early disease progression prior to 3 months (12 weeks) from the
completion of RT.
• More than 2 prior lines for chemotherapy administration. (NOTE: In the
1st line adjuvant setting, combination of Temozolomide (TMZ) with an
experimental agent is considered one line of chemotherapy.).
• Any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other VEG)- or VEGF receptor-mediated targeted agent.
• Any prior treatment with prolifeprospan 20 with carmustine wafer.
• Any prior treatment with an intracerebral agent.
• Receiving additional, concurrent, active therapy for GBM outside of the trial.
• Extensive leptomeningeal disease.
• QTc > 450 msec if male and QTc > 470 msec if female.
• History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Participant with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
• Laboratory results that meet exclusionary parameters.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified