CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study

NCT04147143 | Terminated

• 1 other identifier: CaboCHECK
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.

Conditions

Advanced Renal Cell Carcinoma (All Subtypes); Metastatic Renal Cell Carcinoma (All Subtypes)

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events

  Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment

  through study completion, an average of 1 year

Secondary Outcomes (10)

• number of dose reductions

  through study completion, an average of 1 year

• number of dose interruptions

  through study completion, an average of 1 year

• number of terminations of cabozantinib treatment due to adverse events

  through study completion, an average of 1 year

• ORR

  through study completion, an average of 1 year

• Clinical benefit rate (CBR)

  through study completion, an average of 1 year

Interventions

Documentation OTHER

Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.

Eligibility Criteria

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

Study Population

Adults ≥ 18 years with advanced or metastatic renal cell carcinoma (all subtypes) who have completed treatment with nivolumab or nivolumab plus ipilimumab (any line of systemic therapy) directly followed by cabozantinib treatment

You may qualify if:

• Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject
• Patients with advanced or metastatic renal cell carcinoma, including all subtypes
• Age ≥ 18 years
• Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment

You may not qualify if:

• Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
• Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead

Study Sites (2)

Uniklinik Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Uniklinik Münster

Münster, North Rhine-Westphalia, 48147, Germany

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

• Salah-Eddin Al-Batran, Prof. Dr.

  Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 31, 2019
• Study Start: March 8, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)