Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04147143
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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.

Condition or disease Intervention/treatment
Advanced Renal Cell Carcinoma (All Subtypes) Metastatic Renal Cell Carcinoma (All Subtypes) Other: Documentation

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : March 8, 2020
Estimated Study Completion Date : March 8, 2020



Intervention Details:
  • Other: Documentation
    Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.


Primary Outcome Measures :
  1. Incidence of serious adverse events [ Time Frame: through study completion, an average of 1 year ]
    Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment


Secondary Outcome Measures :
  1. number of dose reductions [ Time Frame: through study completion, an average of 1 year ]
    number of dose reductions

  2. number of dose interruptions [ Time Frame: through study completion, an average of 1 year ]
    number of dose interruptions

  3. number of terminations of cabozantinib treatment due to adverse events [ Time Frame: through study completion, an average of 1 year ]
    number of terminations of cabozantinib treatment due to adverse events

  4. ORR [ Time Frame: through study completion, an average of 1 year ]
    ORR (investigator assessed; acc. RECIST v1.1 if available)

  5. Clinical benefit rate (CBR) [ Time Frame: through study completion, an average of 1 year ]
    Clinical benefit rate (CBR)

  6. Duration of response [ Time Frame: through study completion, an average of 1 year ]
    Duration of response in months

  7. Duration of cabozantinib treatment [ Time Frame: through study completion, an average of 1 year ]
    Duration of cabozantinib treatment in months

  8. Time to next treatment [ Time Frame: From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months ]
    Time to next treatment in months

  9. Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data [ Time Frame: through study completion, an average of 1 year ]
    Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data

  10. Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR) [ Time Frame: through study completion, an average of 1 year ]
    Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147143


Contacts
Layout table for location contacts
Contact: Viktor Grünwald, Prof. Dr. +49201723 ext 3214 viktor.gruenwald@uk-essen.de
Contact: Caroline Schönherr, Dr. +49 (0)697601 ext 4094 schoenherr.caroline@ikf-khnw.de

Locations
Layout table for location information
Germany
Uniklinik Essen Not yet recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
Contact: Viktor Grünwald, Prof. Dr.    +49 201723- ext 3214    viktor.gruenwald@uk-essen.de   
Uniklinik Münster Recruiting
Münster, Nordrhein-Westfalen, Germany, 48147
Contact: Martin Bögemann, PD Dr.         
Sponsors and Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Investigators
Layout table for investigator information
Study Director: Salah-Eddin Al-Batran, Prof. Dr. Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Layout table for additonal information
Responsible Party: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT04147143    
Other Study ID Numbers: CaboCHECK
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases