About this trial
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Patients with histological diagnosis of predominantly clear cell carcinoma
Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years.
Evaluable disease according to RECIST criteria v 1.1
Disqualifiers
Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis
Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib.
Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.
Trial population
patients with metastatic clear cell renal carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment. Cabozantinib treatment receive after one or more previuos therapy for mRCC
Trial design
Cohort
Retrospective
Treatments tested in this trial
Cabozantinib
DrugPatients must have been treated with cabozantinib after one or more previous therapies for mRCC, as per clinical practise.
Treatment groups
Trial outcomes
Primary outcomes
Genomic profiling
to describe genomic profiling of patients with mRCC who are long-lasting responders (PFS ≥9 months) to cabozantinib and describe genomic profiling of patients with rapid disease progression following cabozntinib therapy (PFS≤ 3 months)
Secondary outcomes
Overall Survival (OS)
to describe OS based according to detected genomic profiling
Overall response rate (ORR)
to describe ORR according to the detected genomic profiling
Duration of response (DOR)
to describe duration of response (DOR) according to the detected genomic profilingto describe the genomic profiling according to treatment line (second, third or subsequent) to describe anamnestic characteristics (weight, ECOG PS, sites of metastasis, response to previous treatment lines)
Sponsors and contacts
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