CaboCHECK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-08

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Documentation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Salah-Eddin Al-Batran, Prof. Dr.

Role: STUDY_DIRECTOR

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uniklinik Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Uniklinik Münster

Münster, North Rhine-Westphalia, Germany