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AzTrials

Advanced Cervical CarcinomaPhase 2NCT05521997

Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer

A Phase 2 study testing Telaglenastat, Radiation treatment and Cisplatin in people with Advanced Cervical Carcinoma and Cervical Cancer, run by Washington University School of Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telaglenastat, Radiation treatment and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
31 Dec 2026to 7 Mar 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julie K Schwarz, M.D., Ph.D. contact

314-608-6813

jschwarz@wustl.edu

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Julie K Schwarz, M.D., Ph.D., 314-608-6813, jschwarz@wustl.edu

    Julie K Schwarz, M.D., Ph.D.

Other trials in United States

About this study

Official title: 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.

Being tested
Telaglenastat, Radiation treatment, Cisplatin
Keywords
advanced cervical cancer, Glutaminase Inhibitor
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaglenastatDrug

    Also called CB-893

    -800 mg twice per day by mouth

  • Radiation treatmentRadiation

    • Standard of care
    • External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.

  • CisplatinDrug

    • Standard of care
    • Weekly administration of cisplain
Study groups in NCT05521997
Study groupRoleWhat they receive
Control Arm: Standard of Care ChemoradiationActive comparator-Participants will receive 7 weeks of standard of care chemoradiation.
Receives: Radiation: Radiation treatment; Drug: Cisplatin
Experimental Arm #1: Telaglenastat + Standard of Care ChemoradiationExperimental-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
Receives: Drug: Telaglenastat; Radiation: Radiation treatment; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through completion of follow-up (estimated to be 24 months and 9 weeks)

Secondary outcomes (3)

  1. 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.

    Measured: From start of chemoradiation treatment through 90 days

  2. 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.

    Measured: From day 91 through 24 months after completion of chemoradiation

  3. 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.

    Measured: Through completion of follow-up (estimated to be 24 months and 9 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion7 Mar 2033 (estimated)
  4. Study completion7 Mar 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization will occur on a 5:1 basis to experimental arm and control arm. The first 5 participants randomized to the experimental arm will be considered the safety lead-in.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05521997
Sponsor's protocol ID
202301163
Other IDs
R01CA181745
Status last verified
Aug 2026
First submitted
26 Aug 2022
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaglenastat, Radiation treatment and Cisplatin in people with Advanced Cervical Carcinoma and Cervical Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julie K Schwarz, M.D., Ph.D. (314-608-6813, jschwarz@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) - experimental arm only (time frame: Through completion of follow-up (estimated to be 24 months and 9 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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