Telaglenastat and Chemoradiation for Advanced Cervical Cancer

This study is investigating if adding the drug Telaglenastat to standard chemoradiation (radiation treatment and Cisplatin) can improve outcomes for people with advanced cervical cancer. Researchers believe that Telaglenastat, which is taken by mouth twice a day, along with standard treatment, may help patients live longer without their cancer getting worse (progression-free survival). You may be able to join if you are at least 18 years old, have newly diagnosed advanced cervical cancer (stages III-IVA), and are eligible for standard chemoradiotherapy. The study aims to enroll 42 participants and is currently in an unclear status regarding recruitment.

Study design
This is an interventional study with a planned enrollment of 42 participants. It is testing a combination of Telaglenastat, radiation treatment, and Cisplatin.
What's involved
You would receive Telaglenastat orally twice daily, standard radiation treatment (daily 4 days a week plus weekly brachytherapy), and weekly Cisplatin.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured through completion of follow-up, estimated to be 24 months and 9 weeks.

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NCT05521997

Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington University School of Medicine
~42 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:TelaglenastatRadiation treatmentCisplatin

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) - experimental arm only
Measured over Through completion of follow-up (estimated to be 24 months and 9 weeks)
Advanced Cervical Carcinoma
Cervical Cancer
Cervix Cancer
Cancer of the Cervix
1 sites across 1 states
Missouri1
  • Julie K Schwarz, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

Patient age ≥ 18 years.
Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous, adenosquamous, adenocarcinoma or poorly differentiated); Federation of Gynecology and Obstetrics (FIGO) 2018 clinical stages III-IVA.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Absolute neutrophil count ≥ 1,500/mcL.
Platelets ≥ 100,000/mcL.
Hemoglobin ≥ 8 g/dL (can be transfused prior to study).
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); patients with known Gilbert disease with serum bilirubin ≤ 3 x ULN may be enrolled.
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]/alanine aminotransfersase (ALT) (serum glutamate pyruvate transaminase \[SGPT\] ≤ 2.5 x ULN.
Alkaline phosphatase ≤ 2.5 x ULN.
Serum creatinine ≤ 1.5 mg/dL to receive weekly cisplatin; patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no hydronephrosis and the estimated creatinine clearance (CCr) is ≥ 30 ml/min. For the purpose of estimating the CCr, formulas, including Cockcroft and Gault for females or similar, should be used.
International normalize ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular weight heparin or warfarin, should be on a stable dose).
Patient does not have uncontrolled diabetes mellitus (i.e. fasting blood glucose \>200 mg/dL).
Patient does not have a known allergy to cisplatin or compounds of similar biologic composition as CB-839.
Patient is not actively breastfeeding (or has agreed to discontinue before the initiation of protocol therapy).
Ability to understand and the willingness to sign a written informed consent document.
Patients does not have known human immunodeficiency virus syndrome (HIV testing optional).

Exclusion

Patient has another concurrent active invasive malignancy.
Patient has received prior radiation therapy to the pelvis or previous therapy of any kind for this malignancy, or pelvic radiation for any prior malignancy.
Patient is receiving another investigational agent for the treatment of cancer.
Poorly controlled diabetes, with inability to perform 18F-FDG PET scan.
Patient is pregnant or breastfeeding.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Mean resting QTc \> 470 msec obtained by electrocardiogram (ECG).
Severe, active co-morbidity defined as follows:
Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel obstruction
Patients who require parental hydration and/or nutrition
Patients who require drainage gastrostomy tube
Evidence of bleeding diathesis or clinically significant coagulopathy
Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture
History of hemoptysis (\>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment
Significant cardiovascular or cerebrovascular disease including: Uncontrolled hypertension (systolic blood pressure \[SBP\] \>= 150; diastolic blood pressure \[DBP\] \>= 90)
  • Progression-free survival (PFS) - experimental arm onlyThrough completion of follow-up (estimated to be 24 months and 9 weeks)

    * PFS is defined as the duration of time from start of telaglenastat to time of progression or death, whichever occurs first. * Progressive disease: New foci of abnormal FDG uptake not present on the pretreatment FDG-PET study