A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line (AxiPRO)

May 2, 2022 updated by: Weprom

With the advent of immunotherapy, standard first-line treatment for patients with renal cell carcinoma is now an association with an immune checkpoint inhibitor. In this context, the association axitinib plus pembrolizumab has already been evaluated in several studies with positive results for Progression Free survival, Overall survival and Complete response. The combo received a positive opinion from the Committee for Medicinal Products for Human Use, and the European Commission approves the extension of Marketing Authorization in first line for metastatic renal cell carcinoma patients.

In a context of treatment with a new association, it is important to manage the toxicities closely in order to allow the patients to have an optimal treatment. The underlying hypothesis is that the use of new information and communication technologies could improve clinical patient management.

In this study, we wish assess the impact of monitoring via the web application KidneyPRO on the quality of life of patients with the new combination of treatment axitinib/pembrolizumab for a renal cell carcinoma in first line.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Metastatic or locally advanced clear cell renal carcinomas (RCC) are treated with targeted therapies (inhibitors of tyrosine kinases) and immune check-points inhibitors.

In first line many combos are tested. Association of TKI-PD L1-inhibitor is one option. Axitinib-Pembrolizumab showed very high response rate and progression free survival compared to Sunitinib but immunotherapies have a specific adverse event profile. Actually, there is no standardized follow-up for this type of treatment.

It is important to develop new strategies that reduce the resources used while improving the performance of this surveillance for the benefit of patients, to improve the comfort of patients, to improve the compliance and to optimise the dose of treatment received, in a course of care reworked by maintaining a continuous contact not demanding.

In collaboration with the Scientific Research National Center, the theory of chaos and its derivatives was applied to cancer and a web-application was developed on these concepts to remotely analyze the dynamics of the symptoms felt by the patient and early detect a recurrence or a complication of his cancer. Clinical symptoms are self-assessed by patients once a week, transcribed on their smartphone or computer through the Internet application. Relevant clinical events are detected using data processing algorithms, combining the dynamics of the various reported symptoms. In this case, an alert message is sent to the health care team. The referring oncologist is thus warned early. He can then make a telephone call to the patient about the reality of the medical alert and summon him for a check-up or any other complementary examination.

Applied to lung cancer, this application is a tried-and-tested solution with a phase III clinical trial. The main criteria was overall survival. The monitoring of these patients with the web-application and with a number of scanners reduced by 50% compared to the reference arm, made it possible to diagnose relapses earlier, to treat them under better conditions and, above all, to improve statistically significant overall survival (a gain in overall survival of 26% at 1 year (in patients intending to treat): 49% in the standard arm versus 75% in the experimental arm: p = 0.0025. This profit persists with 2 years of decline (a median gain in overall survival of 7.6 months, p=0.0312).

This concept was confirmed in the NCT0578006 study published by Basch et al. Basch used a similar application during chemotherapy treatment in 766 cancer patients. The web-application has improved overall survival by 5 months (Hazard ratio: 0.83).

This web-application provided a statistical improvement in the quality of life for lung cancer, access to new therapeutic lines (74% versus 33%, p <0.001) and optimally with treatments delivered at therapeutic doses (in 76% versus 34%) and faster access to supportive care for a clear improvement in the general condition of patients (77 versus 33%, p <0.001). The key for these patients who experienced many treatment toxicities was to use a better method of active follow-up.

A real-time survey of quality of life of Renal Cell Cancer patients receiving Axitinib/Pembrolizumab is an objective that has never been evaluated. This study will allow to generate data in patients who were not included in the phase III study (KEYNOTE 426): Performance Status =2, with central nervous system metastasis and with renal insufficiency. Personalized monitoring of these patients with the web-application KidneyPRO is even more relevant because the aim would be to quickly provide care adapted to adverse events, supportive care in case of loss of activity…

The web-application KidneyPRO investigated has been developed for this purpose.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France, 49055
      • Besançon, France, 25000
        • Not yet recruiting
        • Chu Jean Minjoz
        • Contact:
        • Principal Investigator:
          • Antoine THIERY-VUILLEMIN, MD
      • Brest, France, 29000
        • Recruiting
        • Clilnique Pasteur
        • Principal Investigator:
          • Ali Hasbini, MD
      • Brest, France, 29609
      • Caen, France, 14076
        • Not yet recruiting
        • Centre Francois Baclesse
      • La Roche-sur-Yon, France, 85925
      • Le Mans, France, 72000
        • Recruiting
        • Clinique Victor Hugo / Centre Jean Bernard
        • Contact:
      • Lyon, France, 69373
      • Reims, France, 5100
        • Recruiting
        • Institut Jean Godinot
        • Contact:
        • Principal Investigator:
          • Jean-Christophe Eymard, MD
      • Saint-Grégoire, France, 35760
        • Recruiting
        • CHP St Grégoire
        • Principal Investigator:
          • Xavier Artignan, MD
      • Strasbourg, France, 67091
      • Toulouse, France, 31059
        • Not yet recruiting
        • Institut Claudius Regaud
      • Tours, France, 37000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced RCC who require a first line systemic treatment by axitinib/pembrolizumab combo
  2. Patient with at least one measurable lesion according to RECIST 1.1 criteria or with clinically apparent disease that can be reliably monitored by the investigator
  3. Patient aged 18 years or older
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status < 3

  5. Patient with adequate hematopoietic or organ function, as indicated by the following criteria (assessed within -14 days prior the first dosing):

    • WBC > 2 x 109/L
    • Polynuclear neutrophils > 1.5 x 109/L
    • Platelets > 100 x 109/L
    • Hemoglobin > 8.0 g/mL
    • ALT/AST < 2.5 x ULN in the absence of liver metastases or < 5x ULN in the presence of liver metastases
    • Bilirubin < 1.5 x ULN (except Gilbert Syndrome: < 3.0 mg/dL)
    • Creatinine clearance ≥ 30 mL/min (measured or calculated by Cockroft and Gault formula) or serum creatinine < 2.0 x ULN
  6. Patient possessing an initial symptom score less than or equal to 6 (Specific scale: assessment of the importance of 3 symptoms in appendix 1)
  7. Patient has internet access and an email account (or has someone at home who can help send patients' symptoms or complete the form)
  8. Woman of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first administration of study treatment.
  9. Patients who are sexually active must agree to use a highly effective method of contraception (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner, for participating women; condoms for participating men) or practice complete abstinence, beginning 14 days before the first administration of study treatment, while on treatment.
  10. Patient without symptomatic brain metastases (non-symptomatic metastases : without edema, not on corticosteroids, not eligible for radiation therapy/surgery and not receiving active treatments).
  11. Patient enrolled in social security
  12. Patient has given his written consent ahead of any specific protocol procedure

Exclusion Criteria:

  1. Prior systemic therapy directed at advanced or metastatic RCC
  2. Patient with contraindication to a treatment by axitinib/pembrolizumab
  3. Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137 or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways or TKI
  4. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
  5. Uncontrolled hypertension in spite of anti-hypertensive therapy
  6. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
  7. Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism

  8. Current use of immunosuppressive medication, EXCEPT for the following:

    1. intranasal inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
    2. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered as a form of systemic treatment
  10. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo/hyperthyroid diseases not requiring immunosuppressive treatment are eligible
  11. Prior organ transplantation including allogenic stem-cell transplantation
  12. Active serious infections requiring systemic antibiotic or antimicrobial therapy
  13. Known history of testing positive for HIV or known acquired immunodeficiency syndrome
  14. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
  15. History of pneumonitis that required steroids, or current pneumonitis
  16. Vaccination within 4 weeks of the first dose of pembrolizumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)
  17. Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis
  18. Patient deprived of their liberty, under guardianship or trusteeship
  19. Patient is being treated for another cancer and has not been cured
  20. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
  21. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
  22. Patient is pregnant or breastfeeding
  23. Patient is participating in another interventional study of telemonitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Standard follow-up
Patients will have no intervention. It is the comparator group. Patients will have the usual follow-up for clinical, biological and imaging exams.
Other: standard follow-up
usual follow-up
EXPERIMENTAL: KidneyPRO web-application follow up

Patients will have to connect to the KidneyPRO web-application weekly to complete a questionnaire about their symptoms in addition to usual follow-up.

Appropriate care will be offered if necessary (depending on the symptoms assessment)
Device: KidneyPRO
Web-application for symptoms assessment
Other Names:
  • web-application

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
symtom specific Quality Of Life at 24 weeks
Time Frame: 6 months
difference of 4 points of the Quality Of Life, between the two arms, by the FACT-Kidney Symptom Index (FKSI-19) 24 weeks (6 months) after the first treatment administration date. Higher score is worse.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
Calculated from the date of randomization to the date of death due to any cause or the date last known to be alive if patient is censored.
2 years
Progression Free survival
Time Frame: 2 years
Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression
2 years
Treatment Free Survival
Time Frame: 2 years
Evaluated from the date of last administration of treatment to the date of the first administration of the next line of treatment or the date last known to be alive if patient is censored
2 years
Duration Of Response
Time Frame: 2 years
Evaluated from the date of the first documented tumor response to the date of disease progression or the date last known to be alive if patient is censored
2 years
Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
Time Frame: 2 years
TThe FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains- Disease Related Symptoms (physical and emotional), Treatment related side effects and Functional and Well-Being . A negative change from Baseline represents a worsening of condition.
2 years
Change From Baseline in Quality Of life Questionnaire-C30 (QLQ-C30)
Time Frame: 2 years
QLQ-C30 is a generic questionnaire for cancer patients. Score will be calculated according to European Organisation for Research and Treatment of Cancer guidelines for QLQ-C30. . QoL with QLQ-C30 will be evaluated before start of treatment and every 3 months until 24 months and at the end of treatment. A negative change from Baseline represents a worsening of condition.
2 years
Number of patients who experienced an adverse event (AE)
Time Frame: 2 years
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
2 years
Duration of the treatment
Time Frame: 2 years
Calculated from the date of the first administration of the treatment until the last administration of the last treatment in progress
2 years
Time to treatment discontinuation/failure due to toxicity
Time Frame: 2 years
Calculated from the date of the first administration of the treatment until the date of the first discontinuation / failure due to toxicity of one of the 2 molecules
2 years
Description of subsequent cancer treatments
Time Frame: 2 years
Names of subsequant cancer treatments
2 years
Web-application compliance
Time Frame: 2 years
evaluated by the following ratio: the number of completed questionnaires made via the app verus the theoretical number of questionnaires that the included patients should have complete during a given period
2 years
Treatment compliance
Time Frame: 2 years
Evaluated by the number of taken tablets verus.the theoretical number of tablets the patient should have taken during a given period
2 years
Sensibility of the application
Time Frame: 2 years
Evaluated the number of events diagnosed by the app on the number of events that occurred in total.
2 years
Patient web-application satisfaction
Time Frame: 1 year
Evaluated by a specific self-evaluation at the 6th and 12th month follow-up visits (specific questionnaire dedicated to the use of the web-application) and at the end of treatment
1 year
Performance Status at the end of treatment
Time Frame: 2 years
Evaluated with the Eastern Cooperative Oncology Group's recommendations, at each visit
2 years
Medical team web-application satisfaction
Time Frame: 1 year
Evaluated with a specific questionnaire at 12 months.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weprom

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer
FLGXPL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric VOOG, MD, Clinique Victor Hugo/Centre Jean Bernard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WP-2019-03
  • 2020-A01103-36 (OTHER: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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