The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are:

Does niraparib improve progression-free survival (PFS) compared to TMZ?

Does niraparib improve overall survival (OS) compared to TMZ?

Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ.

* study drug (Niraparib) or
* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).

The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.

Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.

Participants' tasks will include:

* Complete study visits as scheduled
* Complete a diary to record study medication

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Oncological Center Chemnitz

Clinical Trials Unit

Clinical Research Informatics & Analytics, Infectious Diseases Research and Care Delivery Research

Ivy Brain Tumor Center

This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment.

A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT

Genenta Science

The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy.

Find clinical trials for Glioblastoma (GBM) in Roma, Lazio

Related conditions:

Glioblastoma (GBM) trials near Roma, Lazio, ITA:

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT (TEM-GBM)

LAM561 With RT and TMZ for Adults With Glioblastoma (CLINGLIO)

Find clinical trials for Glioblastoma (GBM) in .css-epvm6{white-space:nowrap;}Roma, Lazio

Related conditions:

Glioblastoma (GBM) trials near Roma, Lazio, ITA:

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT (TEM-GBM)

LAM561 With RT and TMZ for Adults With Glioblastoma (CLINGLIO)

Find clinical trials for Glioblastoma (GBM) in Roma, Lazio