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Trial record 1 of 1 for:    NCT04555603
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Axitinib Therapy Management 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. Read our disclaimer for details. Identifier: NCT04555603
Recruitment Status : Active, not recruiting
First Posted : September 18, 2020
Last Update Posted : December 21, 2020
Information provided by (Responsible Party):

Brief Summary:
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI

Condition or disease Intervention/treatment
Renal Cell Carcinoma Drug: Inlyta Drug: Bavencio Drug: Keytruda

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Drug: Inlyta
    Other Name: Axitinib as prescribed in the real world
  • Drug: Bavencio
    Other Name: Avelumab as prescribed in the real world
  • Drug: Keytruda
    Other Name: Pembrolizumab as prescribed in the real world

Primary Outcome Measures :
  1. To describe type of immune related adverse events and adverse events related to axitinib [ Time Frame: during treatment period ]
    describe type of immune related adverse events and adverse events related to axitinib

  2. To describe the percentage of patients with documentation of dose modifications [ Time Frame: during treatment period ]
    describe dose modifications

  3. To describe the percentage of patients with usage of concomitant high-dose corticosteroid [ Time Frame: during treatment period ]
    descriptive assessment

  4. To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy [ Time Frame: during study period ]
    calculation of overall survival time

  5. To estimate the best overall response (partial response, complete response, progressive disease, or stable disease [ Time Frame: during treatment period ]
    description of overall response

  6. To estimate time to treatment discontinuation [ Time Frame: during treatment period ]
    calculation of duration of treatment

  7. To estimate PFS [ Time Frame: during treatment period ]
    calculation of progression free survival

Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
academic and community centers

Inclusion Criteria:

  • Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point

    • Age 18 years or older at the time of aRCC diagnosis
    • Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line

Exclusion Criteria:

  • none

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 identifier (NCT number): NCT04555603

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United States, New York
Pfizer Inc.
New York, New York, United States, 10017
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT04555603    
Other Study ID Numbers: A4061096
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action