Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer

March 12, 2026 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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).

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Arm: Standard of Care Chemoradiation
-Participants will receive 7 weeks of standard of care chemoradiation.
Radiation: Radiation treatment
  • Standard of care
  • External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
Drug: Cisplatin
  • Standard of care
  • Weekly administration of cisplain
Experimental: Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
Radiation: Radiation treatment
  • Standard of care
  • External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
Drug: Cisplatin
  • Standard of care
  • Weekly administration of cisplain
Drug: Telaglenastat
-800 mg twice per day by mouth
Other Names:
  • CB-893

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) - experimental arm only
Time Frame: Through 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
Through completion of follow-up (estimated to be 24 months and 9 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute toxicity as measured by number of acute adverse events experienced by participant - experimental arm only
Time Frame: From start of chemoradiation treatment through 90 days
  • 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
Time Frame: From day 91 through 24 months after completion of chemoradiation
  • 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)
Time Frame: Through completion of follow-up (estimated to be 24 months and 9 weeks)
-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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Calithera Biosciences, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julie K Schwarz, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202301163
  • R01CA181745 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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