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Clinical Trial NCT05521997 for Advanced Cervical Carcinoma, Cervical Cancer, Cervix Cancer, Cancer of the Cervix is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer Phase 2 42

Not yet recruiting
Clinical Trial NCT05521997 is designed to study Treatment for Advanced Cervical Carcinoma, Cervical Cancer, Cervix Cancer, Cancer of the Cervix. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 31 July 2026 until the study accrues 42 participants. Led by Washington University School of Medicine, this study is expected to complete by 7 October 2032. The latest data from ClinicalTrials.gov was last updated on 13 March 2026.
Brief Summary
Advanced cervical cancer patients treated with standard of care (SOC) chemoradiation plus glutaminase inhibition with telaglenastat (CB-839) will have increased progression-free survival (PFS) compared to historical rates for patients receiving SOC chemoradiation alone.
Official Title

Phase II Study of Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer

Conditions
Advanced Cervical CarcinomaCervical CancerCervix CancerCancer of the Cervix
Other Study IDs
NCT ID Number
NCT05521997
Start Date (Actual)
2026-07-31
Last Update Posted
2026-03-13
Completion Date (Estimated)
2032-10-07
Enrollment (Estimated)
42
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
advanced cervical cancer
Glutaminase Inhibitor
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorControl Arm: Standard of Care Chemoradiation
-Participants will receive 7 weeks of standard of care chemoradiation.
Radiation treatment
* Standard of care * External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
Cisplatin
* Standard of care * Weekly administration of cisplain
ExperimentalExperimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
Telaglenastat
-800 mg twice per day by mouth
Radiation treatment
* Standard of care * External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
Cisplatin
* Standard of care * Weekly administration of cisplain
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression-free survival (PFS) - experimental arm only
* 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
Through completion of follow-up (estimated to be 24 months and 9 weeks)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Acute toxicity as measured by number of acute adverse events experienced by participant - experimental arm only
* Toxicity evaluation will report events according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) * Acute toxicity is defined as any toxicity occurring within 90 days from first receiving study radiotherapy or death, whatever event is observed first.
From start of chemoradiation treatment through 90 days
Late toxicity as measured by number of late adverse events experienced by participant - experimental arm only
* Toxicity evaluation will report events according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) * Late toxicities include any toxicity that is determined possibly, probably, or definitely related to treatment, within 24 months after completion of treatment.
From day 91 through 24 months after completion of chemoradiation
Overall survival (OS)
-OS is defined as the days from the start of Telaglenastat treatment to the date of death, censored at the last follow-up otherwise.
Through completion of follow-up (estimated to be 24 months and 9 weeks)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

Patients eligible for definitive chemoradiotherapy, including brachytherapy

  • 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).

  • 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)
Washington University School of Medicine logoWashington University School of Medicine462 active studies to explore
Study Central Contact
Contact: Julie K Schwarz, M.D., Ph.D., 314-608-6813, [email protected]
1 Study Locations in 1 Countries

Missouri

Washington University School of Medicine, St Louis, Missouri, 63110, United States
Julie K Schwarz, M.D., Ph.D., Contact, 314-608-6813, [email protected]
Julie K Schwarz, M.D., Ph.D., Principal Investigator
Stephanie Markovina, M.D., Ph.D., Sub-Investigator
Andrea Hagemann, M.D., MSCI, Sub-Investigator
Dineo Khabele, M.D., Sub-Investigator
Lindsay Kuroki, M.D., Sub-Investigator
L. Stewart Massad, M.D., Sub-Investigator
Carolyn McCourt, M.D., Sub-Investigator
Maggie Mullen, M.S., Sub-Investigator
David Mutch, M.D., Sub-Investigator
Matthew Powell, M.D., Sub-Investigator
Premal Thaker, M.D., Sub-Investigator
David DeNardo, Ph.D., Sub-Investigator
Gary Patti, Ph.D., Sub-Investigator
Li Ding, Ph.D., Sub-Investigator
Esther Lu, Ph.D., Sub-Investigator