OncoMatch/Clinical Trials/NCT04555577
Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma
Is NCT04555577 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Peposertib and Temozolomide for glioblastoma.
Treatment: Peposertib · Temozolomide — This phase I trial investigates the side effects and best dose of Peposertib, and to see how well it works in combination with radiation therapy in treating patients with newly diagnosed MGMT unmethylated glioblastoma or gliosarcoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Peposertib may further stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Peposertib with radiation therapy may work better than radiation therapy alone in treating patients with glioblastoma or gliosarcoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
IDH wild-type, per WHO 2021 classification .IDH status is to be determined by IDH1 R132H immunohistochemistry except for patients ≤ age 54 in whom IDH sequencing will be required to detect non-canonical IDH mutations.
Required: MGMT unmethylated
Documentation of MGMT unmethylated GBM per testing at any Clinical Laboratory Improvement Amendment (CLIA) certified laboratory
Disease stage
Required: Stage WHO GRADE 4 (WHO 2021)
Grade: 4 (WHO)
Histologically confirmed World Health Organization (WHO) grade 4 glioma (GBM) or gliosarcoma, IDH wild-type, per WHO 2021 classification
Prior therapy
Must have received: brain surgery or biopsy
Patients must have undergone brain surgery or biopsy and must not have had any further cancer treatments following surgery
Cannot have received: interstitial brachytherapy
Has received prior interstitial brachytherapy or implanted chemotherapy.
Cannot have received: implanted chemotherapy
Has received prior interstitial brachytherapy or implanted chemotherapy.
Cannot have received: re-radiation for GBM
Exception: except for stereotactic radiosurgery
Has not received re-radiation for GBM in the past except for stereotactic radiosurgery
Cannot have received: concomitant chemotherapy, immunotherapy, or radiotherapy (other than as pertained to GBM as described in section 1.1)
Patients may not receive concomitant chemotherapy, immunotherapy, or radiotherapy (other than as pertained to GBM as described in section 1.1) while patients are on study.
Cannot have received: bevacizumab (bevacizumab)
Exception: Patients in stage II C and D (recurrent GBM) may receive bevacizumab as clinically indicated during the adjuvant phase of treatment (physician choice) once 6 weeks has elapsed from the surgery and if there are no wound healing concerns
Prior exposure to bevacizumab. Patients in stage II C and D (recurrent GBM) may receive bevacizumab as clinically indicated during the adjuvant phase of treatment (physician choice) once 6 weeks has elapsed from the surgery and if there are no wound healing concerns
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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