Advanced/Metastatic Cervical CancerPhase 2CABOCOL-01NCT04205799
Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure
A Phase 2 study testing Cabozantinib in people with Advanced/Metastatic Cervical Cancer, run by Centre Francois Baclesse at 8 sites in France.
Trial summary
Assess efficacy and safety of cabozantinib in monotherapy in advanced/metastatic cervical cancer (CC) after failure of platinum-based regimen treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced/Metastatic Cervical Cancer
- What is being tested?
- Cabozantinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Jan 2020to 15 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Institut de cancérologie de l'Ouest
Angers
Centre François Baclesse
Caen
Centre Oscar LAMBRET
Lille
Centre Léon Bérard
Lyon
Institut de Cancérologie de Montpellier
Montpellier
Institut de cancérologie de l'Ouest
Nantes
Institut CURIE
Saint-Cloud
Institut Gustave Roussy
Villejuif
About this study
Official title: A Phase II Study Assessing Safety and Efficacy of Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure
Assess efficacy and safety of cabozantinib in monotherapy in advanced/metastatic cervical cancer (CC) after failure of platinum-based regimen treatment.
- Conditions
- Advanced/Metastatic Cervical Cancer
- Being tested
- Cabozantinib
- Keywords
- cervical cancer, advanced/metastatic, Cabozantinib, platinum treatment failure
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
| Study group | Role | What they receive |
|---|---|---|
| CABOZANTINIB | Experimental | Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Cabozantinib: Proportion of Patients With Disease Control Rate
Efficacy assessed by the proportion of patients with disease control rate. Disease Control Rate (DCR) was defined as the proportion of participants who achieved complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to the study-specific tumor response assessment criteria.
Measured: 3 months after cabozantinib treatment initiation.
Safety of Cabozantinib: Proportion of Patients With Clinical Gastro-intestinal (GI) Perforation/Fistula, GI-vaginal Fistula and Genito-urinary (GU) Fistula Events Grade ≥ 2 (NCI CTCAE v 5.0)
Safety assessed by the proportion of patients with clinical gastro-intestinal (GI) perforation/fistula, GI-vaginal fistula and genito-urinary (GU) fistula events grade ≥ 2 (NCI CTCAE v 5.0)
Measured: toxicities occurring up to 1 month after the end of treatment
Secondary outcomes (5)
Objective Response (RECIST v1.1 Criteria)
Objective response rate defined as the percentage of patients who have achieved complete response or partial response with RECIST 1.1 criteria.
Measured: From treatment start up to 24 months
Progression-free Survival (PFS)
Progression-free survival, defined as the time between initiation of cabozantinib treatment and progression (RECIST 1.1 criteria) or death of any cause whichever occurs first.
Measured: At the end of cycle 3,6,9... (each cycle is 28 days) through study completion, an average of 1 follow-up year
Overall Survival
Overall survival, defined as the time between initiation of cabozantinib treatment and death of whatever cause.
Measured: through study completion, an average of 1 follow-up year
Safety Profile of Cabozantinib
Rate of patients observing at least one toxicity, evaluated according to NCI CTCAE v5.0 criteria. Details will then be given in Adverse Events section.
Measured: every cycle of treatment (each cycle is 28 days) through study completion, an average of 1 follow-up year
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
The EORTC QLQ-C30 is a validated questionnaire used to assess health-related quality of life in cancer patients. It measures global quality of life, functional status, and symptom burden. The EORTC QLQ-CX24 is a cervical cancer-specific module that complements the QLQ-C30 by evaluating disease- and treatment-related symptoms, body image, and sexual functioning. For both questionnaires, raw scores are linearly transformed to a standardized scale ranging from 0 to 100. Higher scores on functional and global quality-of-life scales indicate better functioning and quality of life, whereas higher scores on symptom scales indicate greater symptom severity or more problems. For the QLQ-CX24, higher scores on sexual activity and sexual enjoyment reflect better functioning. In general, high functional scores and low symptom scores indicate a more favorable health-related quality of life.
Measured: At Day 15 of cycle 2 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start15 Jan 2020
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced/Metastatic Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205799
- Sponsor's protocol ID
- 2019-002184-97
- Other IDs
- 2019
- Acronym
- CABOCOL-01
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2019
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coquan E, Brachet PE, Licaj I, Leconte A, Castera M, Lequesne J, Meriaux E, Bonnet I, Lelaidier A, Clarisse B, Joly F. CABOCOL-01 trial: a single-arm phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure. BMC Cancer. 2021 Sep 25;21(1):1054. doi: 10.1186/s12885-021-08758-9.
PubMed 34563169
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Assessing Safety and Efficacy of Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure
- ClinicalTrials.gov ID
- NCT04205799
- Acronym / sponsor ID
- CABOCOL-01 / 2019-002184-97
- Conditions
- Advanced/Metastatic Cervical Cancer
- Keywords
- cervical cancer, advanced/metastatic, Cabozantinib, platinum treatment failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess efficacy and safety of cabozantinib in monotherapy in advanced/metastatic cervical cancer (CC) after failure of platinum-based regimen treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABOZANTINIB | Experimental | Drug: CabozantinibCabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibCabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause. | Drug | CABOZANTINIB |
Primary outcome
Efficacy of Cabozantinib: Proportion of Patients With Disease Control Rate
Time frame: 3 months after cabozantinib treatment initiation.
Efficacy assessed by the proportion of patients with disease control rate. Disease Control Rate (DCR) was defined as the proportion of participants who achieved complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to the study-specific tumor response assessment criteria.
Safety of Cabozantinib: Proportion of Patients With Clinical Gastro-intestinal (GI) Perforation/Fistula, GI-vaginal Fistula and Genito-urinary (GU) Fistula Events Grade ≥ 2 (NCI CTCAE v 5.0)
Time frame: toxicities occurring up to 1 month after the end of treatment
Safety assessed by the proportion of patients with clinical gastro-intestinal (GI) perforation/fistula, GI-vaginal fistula and genito-urinary (GU) fistula events grade ≥ 2 (NCI CTCAE v 5.0)
5 secondary outcomes
Objective Response (RECIST v1.1 Criteria)
Time frame: From treatment start up to 24 months
Progression-free Survival (PFS)
Time frame: At the end of cycle 3,6,9... (each cycle is 28 days) through study completion, an average of 1 follow-up year
Overall Survival
Time frame: through study completion, an average of 1 follow-up year
Safety Profile of Cabozantinib
Time frame: every cycle of treatment (each cycle is 28 days) through study completion, an average of 1 follow-up year
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
Time frame: At Day 15 of cycle 2 (each cycle is 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34563169Coquan E, Brachet PE, Licaj I, Leconte A, Castera M, Lequesne J, Meriaux E, Bonnet I, Lelaidier A, Clarisse B, Joly F. CABOCOL-01 trial: a single-arm phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure. BMC Cancer. 2021 Sep 25;21(1):1054. doi: 10.1186/s12885-021-08758-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabozantinib in people with Advanced/Metastatic Cervical Cancer, run by Centre Francois Baclesse at 8 sites in France.
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 18 inclusion and 17 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: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Cabozantinib: Proportion of Patients With Disease Control Rate (time frame: 3 months after cabozantinib treatment initiation.). The study lists 2 primary outcomes in all. 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 NCT04205799, which also lists 1 linked publication.
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 31 Jul 2026.