Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGruppo Oncologico Italiano di Ricerca Clinica

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Cabozantinib

    Drug

    Patients must have been treated with cabozantinib after one or more previous therapies for mRCC, as per clinical practise.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group A: long-lasting responders1 intervention
Group B: Group B: primary refractories1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
12 months

Secondary outcomes

1

Overall Survival (OS)

to describe OS based according to detected genomic profiling

Time frame
12 months
2

Overall response rate (ORR)

to describe ORR according to the detected genomic profiling

Time frame
12 months
3

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)

Time frame
12 months

Other outcomes

Sponsors and contacts

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