This phase II clinical trial tests whether telaglenastat and chemoradiotherapy (cisplatin and radiation therapy) works to shrink tumors in patients with cervical cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Glutaminase inhibitors, such as telaglenastat, may stop the growth of tumor cells by blocking some of the enzymes, glutaminase, needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, 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 telaglenastat with radiation therapy and cisplatin may work better in treating patients with advanced cervical cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05521997.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Approved
Contact: Julie Kristina Schwarz
Phone: 314-608-6813
PRIMARY OBJECTIVE:
I. To determine the progression- free survival (PFS) of patients with advanced cervical cancer treated with standard of care (SOC) chemoradiotherapy (CRT) plus glutaminase inhibition with telaglenastat.
SECONDARY OBJECTIVES:
I. To evaluate the safety and toxicity profile of telaglenastat in combination with SOC CRT for cervical cancer.
II. To determine the overall survival (OS) rate of patients with locally advanced cervical cancer treated with telaglenastat in combination with SOC CRT.
EXPLORATORY OBJECTIVES:
I. To determine the local recurrence-free survival (LRFS) after telaglenastat in combination with SOC CRT.
II. To determine the distant metastasis-free survival (DMFS) after telaglenastat in combination with SOC CRT.
III. To determine the objective response rate (ORR) of patients with advanced cervical cancer treated with telaglenastat in combination with SOC CRT.
IV. To determine the impact of telaglenastat on the cervix tumor immune microenvironment before and during SOC CRT.
V. To determine whether treatment with telaglenastat increases tumor oxidative stress.
VI. To determine whether telaglenastat response is increased in cervical tumors with PI3K pathway mutations.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive SOC cisplatin intravenously (IV) and radiation therapy (RT). Patients also receive telaglenastat orally (PO). Patients receive fludeoxyglucose F-18 IV and undergo positron emission tomography (PET) scan or computed tomography (CT) scan or magnetic resonance imaging (MRI) as well as blood sample collection on study and during follow-up and tumor biopsy on study.
ARM II: Patients receive SOC cisplatin IV and RT. Patients receive fludeoxyglucose F-18 IV and undergo PET scan or CT scan or MRI as well blood sample collection on study and during follow-up and tumor biopsy on study.
After completion of study treatment, patients are followed up at 6 weeks, 3 months and every 3-4 months thereafter up to 24 months.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorJulie Kristina Schwarz
