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

NCT06548867 | Recruiting

• 1 other identifier: GOIRC-08-2018
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma; Genomic signature; long lasting response; cabozantinib treatment

Outcome Measures

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)

  12 months

Secondary Outcomes (3)

• Overall Survival (OS)

  12 months

• Overall response rate (ORR)

  12 months

• Duration of response (DOR)

  12 months

Study Arms (2)

Group A: long-lasting responders

Patient long-lasting responders (PFS ≥9 months) to cabozantinib

Drug: Cabozantinib

Group B: primary refractories

Patient progressed from the start to cabozantinib therapy within 3 months

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

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

Group A: long-lasting responders; Group B: primary refractories

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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
• Treatment with cabozantinib after one or more previous therapies for mRCC
• Patient progressed from the start to cabozantinib therapy within 3 months or after 9 months
• Any prognosis group according to the IMDC risk score
• Signed informed consent must be obtained for living patients. Patients who died and patient untraceable will be analyzed based on the Authorization no. 9/2016 of the Italian Data Protector Supervisor.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead
• Yghea: collaborator
• Ipsen: collaborator

Study Sites (1)

AUSL-IRCCS of Reggio Emilia

Reggio Emilia, 42123, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Carmine Pinto, MD

  AUSL/IRCCS of Reggio Emilia

  PRINCIPAL INVESTIGATOR

• Cristina Masini, MD

  AUSL/IRCCS of Reggio Emilia

  STUDY CHAIR

• Stefania Di Girolamo, MD

  AUSL/IRCCS of Reggio Emilia

  STUDY CHAIR

Central Study Contacts

Carmine Pinto, MD

CONTACT

+39 0522296614; carmine.pinto@ausl.re.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: May 28, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

IT (1)