Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT05039281|
Recruitment Status : Not yet recruiting
First Posted : September 9, 2021
Last Update Posted : May 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma Recurrent Gliosarcoma||Biological: Atezolizumab Drug: Cabozantinib||Phase 1 Phase 2|
I. To evaluate the safety of atezolizumab in combination with cabozantinib. (Phase I) II. To evaluate the progression-free survival at six months (PFS-6) of atezolizumab in combination with cabozantinib. (Phase II)
I. To evaluate the progression free survival (PFS), overall survival (OS), overall response rate (ORR) and duration of response of atezolizumab in combination with cabozantinib.
I. Profiling tumor immune cell populations (i.e., macrophage migration inhibitory factor [mIF] and immunohistochemistry [IHC] analyses of CD4, CD8, PD1, PD-L1, and PD-L2 expression).
II. Profiling of tumor, e.g., deoxyribonucleic acid (DNA), messenger (m) ribonucleic acid (RNA), microRNA and epigenetic profiling (DNA methylation), whole exome sequencing, RNA sequencing, and microRNA sequencing.
III. Peripheral blood collection for evaluation of circulating chemokines/cytokines.
IV. Stool collection for gut microbiome profiling.
Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 and cabozantinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study to Evaluate the Safety and Clinical Efficacy of Atezolizumab (Anti-PD-L1) in Combination With Cabozantinib in Patients With Recurrent Glioblastoma (rGBM)|
|Estimated Study Start Date :||July 1, 2022|
|Estimated Primary Completion Date :||February 15, 2024|
|Estimated Study Completion Date :||February 15, 2024|
Experimental: Treatment (atezolizumab, cabozantinib)
Patients receive atezolizumab IV over 30-60 minutes on day 1 and cabozantinib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Progression-free survival (PFS) [ Time Frame: At 6 momths ]Will estimate the 6 months PFS distribution using the Kaplan-Meier method.
- Objective response rate [ Time Frame: Up to 3 years ]Will be estimated with exact binomial 95% confidence intervals. Logistic regression will be used to explore the correlations between response rates and correlative markers.
- Incidence of adverse events [ Time Frame: Up to 3 years ]Will be estimated with exact binomial 95% confidence intervals. Adverse events will be tabulated by grade and by their relationship to the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039281
|Contact: Eva Gachimova||(713) email@example.com|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Shiao-Pei S. Weathers 713-792-3908 firstname.lastname@example.org|
|Principal Investigator: Shiao-Pei S. Weathers|
|Principal Investigator:||Shiao-Pei S Weathers||M.D. Anderson Cancer Center|