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Trial record 1 of 1 for:    NCT05361434
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A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults (CaboCombo)

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: NCT05361434
Recruitment Status : Recruiting
First Posted : May 4, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.

Condition or disease
Advanced Renal Cell Carcinoma

Study Design
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Study Type : Observational
Estimated Enrollment : 311 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
Actual Study Start Date : September 26, 2022
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab. [ Time Frame: At 18 months follow up ]

Secondary Outcome Measures :
  1. Tumor median progression-free survival (PFS) time [ Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression ]
    Including clinical and radiographic assessments defined as the time between the start date of cabozantinib in combination with nivolumab and the date of progression or death of any cause. The Kaplan-Meier method will be used to estimate median PFS.

  2. Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR)) [ Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression ]
    Assessed by the investigator

  3. Duration of response (DOR) [ Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression ]
    Defined as the interval from the date of first response (complete or partial) to treatment with cabozantinib in combination with nivolumab, to progressive disease or death

  4. Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)). [ Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression. ]
  5. Time of response (TTR) [ Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression ]
    Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).

  6. Pattern of use of cabozantinib under real-world practice conditions. [ Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression ]
  7. Pattern of use of nivolumab under real-world practice conditions. [ Time Frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression ]
  8. Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs). [ Time Frame: Up to 42 months or disease progression ]
    All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.

  9. Change in disease-related symptoms [ Time Frame: Change from baseline at each visit up to 42 months ]
    Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire

  10. Change in pain [ Time Frame: Change from baseline at each visit up to 42 months ]
    Assessed by the Numerical Pain Rating Scale (NPRS)

  11. Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation [ Time Frame: Up to 42 months. ]
    Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will include participants with advanced renal cell carcinoma with clear cell component, for whom a decision to treat with cabozantinib and nivolumab in combination has been made by the treating physician
Criteria

Inclusion Criteria:

  • Participants with diagnosis of aRCC with clear-cell component
  • Participants with no prior systemic treatment for aRCC with clear-cell component;
  • Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels;

Exclusion Criteria:

  • Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study;
  • History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.
Contacts and Locations
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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): NCT05361434


Contacts
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Contact: Ipsen Recruitment Enquiries see email clinical.trials@ipsen.com

Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT05361434    
Other Study ID Numbers: CLIN-60000-452
First Posted: May 4, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
Time Frame: Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
Access Criteria: Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
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