Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal… (NCT03945773) | Clinical Trial Compass
CompletedPhase 2
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
Austria, France127 participantsStarted 2020-01-08
Plain-language 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 CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
✓. 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:
Exclusion criteria
✕. 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;
What they're measuring
1
Cohort A: Objective Response Rate (ORR) Assessed by Independent Central Review
Timeframe: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months
✕. 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;
✕. 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;