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OncoMatch/Clinical Trials/NCT05039281

Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma

Is NCT05039281 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Atezolizumab and Cabozantinib for recurrent glioblastoma.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT05039281Data as of May 2026

Treatment: Atezolizumab · CabozantinibThis phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help control the disease in patients with recurrent glioblastoma.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Disease stage

Required: Stage IV (World Health Organization)

Grade: IV (World Health Organization)

World Health Organization grade IV glioma (glioblastoma or gliosarcoma)

Prior therapy

Must have received: radiation therapy

Patients must have been previously treated with radiation and temozolomide

Must have received: alkylating agent (temozolomide)

Patients must have been previously treated with radiation and temozolomide

Cannot have received: interstitial brachytherapy

Has received prior interstitial brachytherapy

Cannot have received: implanted chemotherapy (Gliadel)

implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. Prior treatment with Gliadel wafers will be excluded.

Cannot have received: local injection or convection enhanced delivery

therapeutics delivered by local injection or convection enhanced delivery

Cannot have received: Optune device

Active treatment with the Optune device will be excluded

Cannot have received: anti-PD-1 therapy

Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Cannot have received: anti-PD-L1 therapy

Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Cannot have received: cytotoxic chemotherapy

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment

Cannot have received: biologic therapy

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment

Cannot have received: systemic anticancer therapy

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment

Cannot have received: small molecule kinase inhibitor

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment

Cannot have received: anti-angiogenic therapy

Prior treatment with anti-angiogenic (e.g. anti-vascular endothelial growth factor [VEGF]) therapeutic antibody or pathway targeting agents

Cannot have received: systemic immunostimulatory agent (interferon, interleukin-2)

Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]- or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1

Cannot have received: systemic immunosuppressive medication (prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF agents)

Exception: acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled; inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed

Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1

Cannot have received: allogeneic bone marrow transplantation

Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation

Cannot have received: solid organ transplantation

Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation

Lab requirements

Blood counts

ANC >= 1,500 /mcL; Platelets >= 100,000 /mcL; Hemoglobin >= 9 g/dL or >= 5.6 mmol/L; INR or PT or aPTT <= 1.3 X ULN

Kidney function

Serum creatinine <= 1.5 X ULN OR measured or calculated creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN; Urine protein/creatinine ratio (UPCR) <= 1 mg/mg OR 24 hour urine protein <= 1g

Liver function

Serum total bilirubin <= 1.5 X ULN OR direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT <= 2.5 X ULN; Serum albumin >= 2.8 g/dl

Cardiac function

QTcF <= 500 ms per ECG within 14 days before first dose of study treatment

ANC >= 1,500 /mcL; Platelets >= 100,000 /mcL; Hemoglobin >= 9 g/dL or >= 5.6 mmol/L; Serum creatinine <= 1.5 X ULN OR measured or calculated creatinine clearance >= 60 mL/min; Urine protein/creatinine ratio (UPCR) <= 1 mg/mg OR 24 hour urine protein <= 1g; Serum total bilirubin <= 1.5 X ULN OR direct bilirubin <= ULN; AST and ALT <= 2.5 X ULN; Serum albumin >= 2.8 g/dl; INR or PT or aPTT <= 1.3 X ULN; QTcF <= 500 ms per ECG

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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