Could a targeted drug shrink advanced cervical tumors?
NCT ID NCT04205799
First seen Jun 29, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This phase 2 trial tests the drug cabozantinib in women with advanced or metastatic cervical cancer that has worsened after platinum-based chemotherapy. The study aims to see if cabozantinib can control the disease and how safe it is, particularly regarding risks like fistulas. Participants take a daily 60 mg pill in 4-week cycles until the cancer progresses or side effects become too severe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cabozantinib
- What this could lead to
- If effective, cabozantinib could offer a new treatment option for advanced cervical cancer when standard chemotherapy stops working.
- What could go wrong
- This is a small, early-phase trial, so results may not confirm benefit. Cabozantinib can cause serious side effects like fistulas or perforations in the gut or urinary tract.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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57 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Jan 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female 18 years of age or older * Histologically confirmed recurrent unresectable or metastatic cervix carcinoma with squamous cell, adenocarcinoma or adenosquamous histology - - Patient may have received at least one prior chemotherapy regimen of platinum-based chemotherapy for recurrence or metastatic disease. * Cisplatin given in combination with radiation for a localized disease does not count as a prior chemotherapy. * Prior treatment for advanced/metastatic disease with bevacizumab is allowed. * Prior treatments with immune checkpoint inhibitors are allowed. - ECOG performance status 0-2 - Measurable disease per RECIST 1.1 * The subject must have recovered to baseline or CTCAE v.5.0 (Common Terminology Criteria for Adverse Events, version 5.0) ≤ Grade 1 from clinical toxicities related to any prior treatments, i.e chemotherapy or pelvis radiation unless AE(s) are clinically non-significant (for example alopecia) * Adequate organ and marrow function, defined as follows, based upon laboratory tests performed within 7 days before inclusion: * Absolute neutrophil count (ANC) ≥ 1000/mm3 (≥ 1.0 GI/L) * Platelets ≥ 100,000/mm3 (≥ 100 GI/L) * Hemoglobin ≥ 10 g/dL (≥ 100 g/L) (red blood cell transfusion is allowed) * Total bilirubin ≤ 1.5 fold the upper limit of normal (for subjects with Gilbert's disease, ≤ 3 mg/dL or ≤ 51.3 μmol/L) o Serum albumin ≥ 3.0 g/dL (≥ 30 g/L) * Calculated creatinine clearance ≥ 30 mL/min by the CKD-EPI method. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3.0 x the upper limit of normal * Urine protein/creatinine ratio (UPCR) ≤ 1g/g (≤ 113.17 mg/mmol creatinine) or 24-hour urine protein \< 1 g * Left-ventricular ejection fraction ≥ 50% * Subjects affiliated to an appropriate social security system * Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib. Effective methods of contraception should be used throughout the course of treatment and for at least 4 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 4 months after the last dose of study treatment, even if oral contraceptives are also used. * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding and/or fistula / perforation including, but not limited to: Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), history of abdomino and/or pelvic fistula, gastrointestinal perforation, or intra-abdominal abscess, gastro-intestinal obstruction * Patients with lesions on baseline pelvic MRI which may major the risk of abdominal and/or pelvic fistula/perforation * Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel. * Previously identified allergy or hypersensitivity to components of the study treatment formulations (Note: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cabozantinib and are also excluded). * History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA), serious cardiac arrythmias. * Corrected QT interval (QTc) calculated by the Fridericia formula \> 500 msec within 28 days before inclusion (see Annex for Fridericia formula). Note: if initial QTcF is found to be \> 500 msec, two additional ECGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 msec, the subject meets eligibility in this regard. * Uncontrolled hypertension defined as systolic blood pressure (SBP) of \> 150 mmHg or diastolic blood pressure (DBP) of \> 100 mmHg despite an optimal treatment. * History of cerebrovascular accident including transient ischemic attack (TIA), symptomatic pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT or asymptomatic pulmonary embolism who have been treated with therapeutic anti-coagulating agents for at least 4 weeks are eligible. * Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer. * Evidence of active bleeding or pathologic conditions that carry high risk of bleeding such as coagulopathy or tumor involving major vessels. * At least 6 weeks must have elapsed between the last dose of pelvis palliative radiation and the first dose of cabozantinib or 2 weeks for other localization of palliative radiation * Presence of brain metastases or epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before inclusion. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of inclusion. * Concomitant use of known strong CYP3A4 inhibitors or inducers. * Patients with second primary cancer, except adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * Concurrent participation in any therapeutic clinical trial * Patient deprived of liberty or placed under the authority of a tutor
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre François Baclesse
Caen, France
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Centre Léon Bérard
Lyon, France
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Centre Oscar LAMBRET
Lille, France
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Institut CURIE
Saint-Cloud, France
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Institut Gustave Roussy
Villejuif, France
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Institut de Cancérologie de Montpellier
Montpellier, France
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Institut de cancérologie de l'Ouest
Angers, France
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Institut de cancérologie de l'Ouest
Nantes, France