Locally Advanced or Metastatic Renal Cell CarcinomaPhase 2CaboPointNCT03945773
Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors
A Phase 2 study testing Cabozantinib in people with Locally Advanced or Metastatic Renal Cell Carcinoma, run by Ipsen at 40 sites in 7 countries.
Trial summary
The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Renal Cell Carcinoma
- 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
- 127 participants
- Where
- 40 sitesin 7 countries
- Study dates
- 8 Jan 2020to 12 Feb 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must fulfil all the following criteria to be included in the study:
- Subjects must provide a signed informed consent prior to any study-related procedures;
- Male or female subjects must be aged ≥18 years on the day the informed consent is signed;
- Subjects must have histologically confirmed unresectable, locally advanced (defined as disease not eligible for curative surgery or radiation therapy) or metastatic RCC with a clear-cell carcinoma component;
- Subjects must have radiographic disease progression, according to Investigator's judgement following 1st line treatment with CPI (ipilimumab plus nivolumab) (Cohort A) or CPI in combination with VEGF-targeted therapy (Cohort B);
- Subjects present ≥1 target lesion according to RECIST 1.1 per Investigator;
Show all 23Show fewer
- Subjects should have Eastern Cooperative Oncology Group (ECOG) status 0-1;
- Subjects with treated brain metastases are eligible if metastases have been shown to be stable as per Investigator's judgement;
- Subjects must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 15 days before baseline:
- Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L).
- Platelets ≥ 100,000/mm3 (≥ 100 GI/L).
- Haemoglobin ≥ 9 g/dL (≥ 90 g/L).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 × upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 × ULN. For subjects with Gilbert's disease ≤ 3 mg/dL (≤ 51.3 μmol/L).
- Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockcroft-Gault equation
- Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine or 24-hour urine protein < 1 g.
- Subject must have recovered to baseline or ≤ Grade 1 per CTCAE v5 from toxicities related to any prior treatments, unless Adverse Events (AE(s)) are clinically nonsignificant and/or stable on supportive therapy as determined by the Investigator;
- Subject must have completed a steroid taper if he/she had an immune-related adverse event associated with immune CPI;
- Female subjects of childbearing potential (i.e. less than or equal to 2 years postmenopause and not surgically sterile) must provide a negative pregnancy test within 7 days prior to the start of study treatment. If a urine test cannot be confirmed as negative, a negative serum pregnancy test is required;
- Female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile) and their partners must agree to use highly effective methods of contraception that alone or in combination result in a failure rate of less than 1% per year when used consistently and correctly during the course of the study and for 4 months after the last dose of study treatment;
- All male participants must agree to refrain from donating sperm and unprotected sexual intercourse with female partners during the study and for 120 days after the last dose of study treatment;
- Subjects must be willing and able to comply with study requirements, remain at the investigational site for the required duration of each study visit and be willing to return to the investigational site for the follow up evaluation, as specified in the protocol
- Subjects must be covered by social security or be the beneficiary of such a system (only applicable for French subjects).
Who cannot join
- Subjects will not be included in the study if the subject:
- Inability to swallow tablets;
- Was treated with any other investigational medicinal product (IMP) within the last 30 days before baseline;
- Was previously treated with cabozantinib;
- Has a contraindication to Magnetic Resonance Imaging (MRI) or contrast medium used for Contrast Tomography (CT)-scan;
- Presents untreated brain or leptomeningeal metastases, or current clinical or radiographic progression of known brain metastases;
Show all 36Show fewer
- Has a diagnosis of a serious cardiovascular disorder:
- Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, or serious cardiac arrhythmias;
- Uncontrolled hypertension, defined as sustained blood pressure (BP) (>140 mm Hg systolic or >90 mm Hg diastolic pressure) despite optimal antihypertensive treatment;
- Stroke (including transient ischaemic attack (TIA)), myocardial infarction (MI) or other ischaemic event, or thromboembolic event (e.g. deep venous thrombosis, pulmonary embolism) within 6 months before screening;
- History of risk factors for torsades de pointes (e.g., long QT syndrome);
- Is receiving concomitant anticoagulation with coumarin agents (e.g. warfarin), direct thrombin inhibitor dabigatran, Direct Factor Xa inhibitors betrixaban or platelet inhibitors (e.g. clopidogrel); Note: The following are allowed anticoagulants: prophylactic use of low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparin (LMWH) are permitted. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in patients without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before baseline without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumour.
- Has a gastrointestinal (GI) disorder including those associated with a high risk of perforation or fistula formation:
- Tumours invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction; b) Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before screening; Note: Complete healing of an intra-abdominal abscess must have been confirmed before screening
- Presents a corrected QT (QTc) interval calculated by the Fridericia formula (QTcF) > 500 msec within 1 month prior to baseline; Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility
- Presents clinically significant haematuria, hematemesis, or haemoptysis of >0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g.
- pulmonary haemorrhage) within 3 months before screening;
- Presents cavitating pulmonary lesion(s) or known endobronchial disease manifestation;
- Presents lesions invading major pulmonary blood vessels;
- Has been diagnosed with other clinically significant disorders such as:
- Serious nonhealing wound/ulcer/bone fracture;
- Malabsorption syndrome;
- Uncompensated/symptomatic hypothyroidism;
- Moderate to severe hepatic impairment (Child-Pugh B or C);
- Requirement for haemodialysis or peritoneal dialysis;
- History of solid organ transplantation;
- Has a predicted life expectancy of less than 3 months;
- Has had prior surgery within 4 weeks prior to baseline. Note: If the subject has undergone major surgery, complete wound healing must have occurred 1 month prior to baseline
- Has had palliative radiation therapy for bone within 2 weeks or for radiation fields including viscera within 4 weeks prior to baseline. Note: Resolution/healing of side effects must be complete prior to baseline;
- Has a history of another active malignancy within 3 years from screening except for locally curable cancers that have been apparently cured, such as low-grade thyroid carcinoma, prostate cancer not requiring treatment (Gleason Grade ≤6), basal or squamous cell skin cancer, superficial bladder cancer, in situ melanoma, in situ prostate, cervix or breast carcinoma or other treated malignancies with <5% chance of relapse according to the Investigator;
- Has a history of allergy to study treatment components or agents with a similar chemical structure or any excipient used in the formulation as listed in the Summary of Product Characteristics (SmPC) document;
- Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded;
- Has a serious medical or psychiatric condition that renders the subject unable to understand the nature, scope and possible consequences of the study, and/or presents an uncooperative attitude;
- Is pregnant or breastfeeding. A β-human chorionic gonadotrophin (HCG) serum pregnancy test will be performed up to 7 days prior to baseline for all female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile);
- Is likely to require treatment during the study with drugs that are not permitted by the study protocol;
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
France12 sites
CHRU Besançon
Besançon, 25000
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13009
Institut de Cancérologie de Lorraine
Nancy, 54511
CHU de Nîmes - Institut de Cancérologie du Gard
Nîmes, 30029
Institut Mutualiste Montsouris
Paris, 75014
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
CHU Strasbourg
Strasbourg, 67091
Institut Claudius Régaud
Toulouse, 31059
Gustave Roussy
Villejuif, 94805
Germany11 sites
Universitätsmedzin Charité
Berlin, D-10117
University Hospital Carl Gustav Carus Dresden
Dresden, D-1307
Universitätsklinikum Essen
Essen, D-45147
University Cancer Center Hamburg Eppendorf
Hamburg, d-20246
Medizinische Hochschule Hannover
Hanover, D-30625
Klinikum Der Friedrich-Schiller-Universitaet Jena
Jena, D-07747
Universitätsklinikum Schleswig-Holstein
Lübeck, D-23538
Otto-von-Guericke-Universität University hospital Magdeburg
Magdeburg, D-39120
University, Hospital Münster
Münster, D-48149
Caritas Krankenhaus St.Josef Klinik für Urologie
Regensburg, D-93053
University Hospital Tuebingen
Tübingen, D-72076
United Kingdom5 sites
Western General Hospital - Edinburgh Cancer Centre
Edinburgh, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
The Christie NHS Foundation Trust
Manchester, M20 4BX
Mount Vernon Hospital
Northwood, HA6 2RN
Royal Cornwall Hospital (RCH) - Sunrise Centre
Truro, TR1 3LJ
Netherlands4 sites
The Netherlands Cancer Institute - Oncology
Amsterdam, 1066 CX
Maxima Medisch Centrum
Eindhoven, 5604 DB
Leiden University Medical Center
Leiden, 2300-RC
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Spain4 sites
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Hospital Lucus Augusti
Lugo, 27003
M.D. Anderson Center Madrid
Madrid, 28033
Hospital Universitario 12 de Octubre
Madrid, 28041
Switzerland3 sites
Universitätsspital Bern, Inselspital
Bern, 3010
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Kantonsspital St. Gallen
Sankt Gallen, 9007
About this study
Official title: A Phase II, Multicentre, Open-label Study of Cabozantinib as 2nd Line Treatment in Subjects With Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors.
The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.
- Being tested
- Cabozantinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Also called Cabometyx
Oral tablets of 60mg, 40mg and 20 mg.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Subjects who radiographically progressed after one prior line by CPI therapy with ipilimumab and nivolumab. Receives: Drug: Cabozantinib |
| Cohort B | Experimental | Subjects who radiographically progressed after one prior line by CPI therapy combined with VEGF-targeted therapy. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A: Objective Response Rate (ORR) Assessed by Independent Central Review
ORR was defined as the percentage of participants who achieved a partial response (PR) or complete response (CR) at any timepoint as determined by independent central review per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The confidence interval of the ORR was calculated using Clopper-Pearson exact method.
Measured: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Secondary outcomes (8)
Time to Response (TTR) Assessed by Independent Central Review and Investigator
TTR was defined as the time from start of study treatment to the date of first evidence of response (PR or CR as determined by independent central review and Investigator per RECIST 1.1). The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Measured: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Duration of Response (DOR) Assessed by Independent Central Review and Investigator
DOR was defined as the time from first documented response (PR or CR as determined by independent central review and Investigator per RECIST 1.1) to either disease progression (as determined by independent central review and Investigator per RECIST 1.1) or death due to any cause, whichever occurs first. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of ≥ 5 millimeters (mm). DOR was calculated using the Kaplan-Meier method.
Measured: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Disease Control Rate (DCR) Assessed by Independent Central Review and Investigator
DCR was defined as the percentage of participants who achieved a PR, CR or stable disease (SD) as determined by independent central review and Investigator per RECIST 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. The PD was defined at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of ≥ 5 mm.
Measured: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Progression-free Survival (PFS) Assessed by Independent Central Review and Investigator
PFS was defined as the time from start of study treatment to either disease progression (as determined by independent central review and Investigator per RECIST 1.1) or death due to any cause, whichever occurs first. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of ≥ 5 mm. PFS was calculated using the Kaplan-Meier method.
Measured: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Cohort B: Objective Response Rate Assessed by Independent Central Review
ORR was defined as the percentage of participants who achieved a PR or CR at any timepoint as determined by independent central review per RECIST 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The CI of the ORR was calculated using Clopper-Pearson exact method.
Measured: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Objective Response Rate Assessed by Investigator
ORR was defined as the percentage of participants who achieved a PR or CR at any timepoint as determined by Investigator per RECIST 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The CI of the ORR was calculated using Clopper-Pearson exact method.
Measured: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Overall Survival (OS) Assessed by Investigator
OS was defined as the time from the start of treatment until death due to any cause. OS was calculated using the Kaplan-Meier method.
Measured: From the start of study treatment (Day 1) up to end of study, 45 months
Change From Baseline in Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI-DRS) Score at Month 40
The FKSI-DRS questionnaire consisted of 9-items to evaluate participant's symptoms in the past 7 days such as lack of energy, pain, weight-loss, bone-pain, shortness of breath, fatigue, fever, blood in urine etc. Participants rated each question from 0 (not at all) to 4 (very much). Total score was calculated as the sum of the item responses divided by the number of items completed and multiplied by the total number of items in the scale. Total score ranged from 0 to 36. Higher scores indicated less symptoms. Baseline was defined as the last questionnaire answered prior to the first dose of study drug. A negative change from baseline indicated worse outcome.
Measured: Baseline (Day 1) and Month 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start8 Jan 2020
- Primary completion11 May 2023
- Study completion12 Feb 2026
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 Locally Advanced or Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945773
- Sponsor's protocol ID
- F-FR-60000-023
- Other IDs
- 2018-002820-18, 2024-514479-16-00, 2018
- Acronym
- CaboPoint
- Status last verified
- Sep 2026
- First submitted
- 9 May 2019
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Publications
Albiges L, Schmidinger M, Taguieva-Pioger N, Perol D, Grunwald V, Guemas E. CaboPoint: a phase II study of cabozantinib as second-line treatment in patients with metastatic renal cell carcinoma. Future Oncol. 2022 Mar;18(8):915-926. doi: 10.2217/fon-2021-1006. Epub 2021 Dec 16.
PubMed 34911359
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Open-label Study of Cabozantinib as 2nd Line Treatment in Subjects With Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors.
- ClinicalTrials.gov ID
- NCT03945773
- Acronym / sponsor ID
- CaboPoint / F-FR-60000-023
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: CabozantinibSubjects who radiographically progressed after one prior line by CPI therapy with ipilimumab and nivolumab. |
| Cohort B | Experimental | Drug: CabozantinibSubjects who radiographically progressed after one prior line by CPI therapy combined with VEGF-targeted therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects must provide a signed informed consent prior to any study-related procedures;
- Male or female subjects must be aged ≥18 years on the day the informed consent is signed;
- Subjects must have histologically confirmed unresectable, locally advanced (defined as disease not eligible for curative surgery or radiation therapy) or metastatic RCC with a clear-cell carcinoma component;
- Subjects must have radiographic disease progression, according to Investigator's judgement following 1st line treatment with CPI (ipilimumab plus nivolumab) (Cohort A) or CPI in combination with VEGF-targeted therapy (Cohort B);
- Subjects present ≥1 target lesion according to RECIST 1.1 per Investigator;
Key exclusion criteria (36 listed)
- Inability to swallow tablets;
- Was treated with any other investigational medicinal product (IMP) within the last 30 days before baseline;
- Was previously treated with cabozantinib;
- Has a contraindication to Magnetic Resonance Imaging (MRI) or contrast medium used for Contrast Tomography (CT)-scan;
- Presents untreated brain or leptomeningeal metastases, or current clinical or radiographic progression of known brain metastases;
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 |
|---|---|---|
| CabozantinibAlso: CabometyxOral tablets of 60mg, 40mg and 20 mg. | Drug | Cohort A, Cohort B |
Primary outcome
Cohort A: Objective Response Rate (ORR) Assessed by Independent Central Review
Time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
ORR was defined as the percentage of participants who achieved a partial response (PR) or complete response (CR) at any timepoint as determined by independent central review per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The confidence interval of the ORR was calculated using Clopper-Pearson exact method.
8 secondary outcomes
Time to Response (TTR) Assessed by Independent Central Review and Investigator
Time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Duration of Response (DOR) Assessed by Independent Central Review and Investigator
Time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Disease Control Rate (DCR) Assessed by Independent Central Review and Investigator
Time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Progression-free Survival (PFS) Assessed by Independent Central Review and Investigator
Time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Cohort B: Objective Response Rate Assessed by Independent Central Review
Time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Objective Response Rate Assessed by Investigator
Time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
Overall Survival (OS) Assessed by Investigator
Time frame: From the start of study treatment (Day 1) up to end of study, 45 months
Change From Baseline in Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI-DRS) Score at Month 40
Time frame: Baseline (Day 1) and Month 40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34911359Albiges L, Schmidinger M, Taguieva-Pioger N, Perol D, Grunwald V, Guemas E. CaboPoint: a phase II study of cabozantinib as second-line treatment in patients with metastatic renal cell carcinoma. Future Oncol. 2022 Mar;18(8):915-926. doi: 10.2217/fon-2021-1006. Epub 2021 Dec 16.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Related trials for Locally Advanced or Metastatic Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
Active, not recruitingPhase 3
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
Papillary Renal Cell Carcinoma
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.
Ipsen Medical Director study director
Ipsen
40 sites in 7 countries: 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 Locally Advanced or Metastatic Renal Cell Carcinoma, run by Ipsen at 40 sites in 7 countries.
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 23 inclusion and 36 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France, Germany, United Kingdom, Netherlands, Spain and 2 more countries. 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 19 Dec 2024). 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?
Cohort A: Objective Response Rate (ORR) Assessed by Independent Central Review (time frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months). 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 NCT03945773, 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 6 Oct 2026.