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Renal Cell Carcinoma MetastaticPhase 3AxiPRONCT04764487

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

A Phase 3 study testing KidneyPRO and standard follow-up in people with Renal Cell Carcinoma Metastatic, run by Weprom at 13 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma Metastatic
What is being tested?
KidneyPRO and standard follow-up
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
13 sitesFrance
Study dates
7 Jun 2021to 15 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed advanced RCC who require a first line systemic treatment by axitinib/pembrolizumab combo
  • 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
  • Patient aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
  • 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
Show all 19Show fewer
  • 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
  • Patient possessing an initial symptom score less than or equal to 6 (Specific scale: assessment of the importance of 3 symptoms in appendix 1)
  • Patient has internet access and an email account (or has someone at home who can help send patients' symptoms or complete the form)
  • Woman of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first administration of study treatment.
  • 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.
  • Patient without symptomatic brain metastases (non-symptomatic metastases : without edema, not on corticosteroids, not eligible for radiation therapy/surgery and not receiving active treatments).
  • Patient enrolled in social security
  • Patient has given his written consent ahead of any specific protocol procedure

Who cannot join

  • Prior systemic therapy directed at advanced or metastatic RCC
  • Patient with contraindication to a treatment by axitinib/pembrolizumab
  • 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
  • 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)
  • Uncontrolled hypertension in spite of anti-hypertensive therapy
  • 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
Show all 26Show fewer
  • Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
  • Current use of immunosuppressive medication, EXCEPT for the following:
  • intranasal inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
  • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • 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
  • 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
  • Prior organ transplantation including allogenic stem-cell transplantation
  • Active serious infections requiring systemic antibiotic or antimicrobial therapy
  • Known history of testing positive for HIV or known acquired immunodeficiency syndrome
  • 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)
  • History of pneumonitis that required steroids, or current pneumonitis
  • 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)
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis
  • Patient deprived of their liberty, under guardianship or trusteeship
  • Patient is being treated for another cancer and has not been cured
  • Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
  • Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
  • Patient is pregnant or breastfeeding
  • Patient is participating in another interventional study of telemonitoring

Trial locations and contacts

13 sites in 1 country.

Magali BALAVOINE contact

2 41 68 29 70 ext. +33

m.balavoine@weprom.fr

13 sites in 1 country

France13 sites, 13 recruiting

  • Institut de Cancérologie de l'Ouest

    Angers, 49055

    Sophie ABADIE-LACOURTOISIE, MD, sophie.abadie-lacourtoisie@ico-unicancer.fr

    Sophie ABADIE-LACOURTOISIE, MD

    Not yet recruiting

  • CHU Jean Minjoz

    Besançon, 25000

    Antoine THIERY-VUILLEMIN, MD, a.thieryvuillemin@mac.com

    Antoine THIERY-VUILLEMIN, MD

    Not yet recruiting

  • Clilnique Pasteur

    Brest, 29000

    Ali HASBINI, MD, alihasbini@oncologie-brest.fr

    Ali HASBINI, MD

    Recruiting

  • CHRU Brest

    Brest, 29609

    FRIEDERIKE SCHLURMANN, MD, friederike.schlurmann@chru-brest.fr

    Friederike SCHLURMANN, MD

    Not yet recruiting

  • Centre François Baclesse

    Caen, 14076

    FLorence JOLY, MD, f.joly@baclesse.unicancer.fr

    Florence JOLY, MD

    Not yet recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925

    Frank PRIOU, MD, frank.priou@chd-vendee.fr

    Frank PRIOU, MD

    Recruiting

  • Clinique Victor Hugo / Centre Jean Bernard

    Le Mans, 72000

    Eric VOOG, MD, e.voog@cjb72.org

    Eric VOOG, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Sylvie NEGRIER, MD, sylvie.negrier@lyon.unicancer.fr

    Sylvie NEGRIER, MD

    Not yet recruiting

  • Institut Jean Godinot

    Reims, 5100

    Jean-Christophe EYMARD, MD, jc.eymard@reims.unicancer.fr

    Jean-Christophe EYMARD, MD

    Recruiting

  • CHP St Grégoire

    Saint-Grégoire, 35760

    Xavier ARTIGNAN, MD, xartignan@vivalto-sante.com

    Xavier ARTIGNAN, MD

    Recruiting

  • Hôpitaux universitaires de Strasbourg

    Strasbourg, 67091

    Gabriel MALOUF, MD, gabriel.malouf@chru-strasbourg.fr

    Gabriel MALOUF, MD

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Christine CHEVREAU, MD, chevreau.christine@iuct-oncopole.fr

    Christine CHEVREAU, MD

    Not yet recruiting

  • CHU Bretonneau

    Tours, 37000

    Berengère NARCISO, MD, berengere.narciso@univ-tours.fr

    Bérengère NARCISO, MD

    Not yet recruiting

Other trials in France

About this study

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.

Read the 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.

Being tested
KidneyPRO, standard follow-up
Keywords
Web-application, Quality Of Life, Metastatic renal cell carcinoma, Follow-up, Progression Free Survival, Overall Survival
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KidneyPRODevice

    Also called web-application

    Web-application for symptoms assessment

  • standard follow-upOther

    usual follow-up

Study groups in NCT04764487
Study groupRoleWhat they receive
Standard follow-upOtherPatients will have no intervention. It is the comparator group. Patients will have the usual follow-up for clinical, biological and imaging exams.
Receives: Other: standard follow-up
KidneyPRO web-application follow upExperimentalPatients 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)
Receives: Device: KidneyPRO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. symtom specific Quality Of Life at 24 weeks

    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.

    Measured: 6 months

Secondary outcomes (16)

  1. Overall survival

    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.

    Measured: 2 years

  2. Progression Free survival

    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

    Measured: 2 years

  3. Treatment Free Survival

    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

    Measured: 2 years

  4. Duration Of Response

    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

    Measured: 2 years

  5. Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19

    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.

    Measured: 2 years

  6. Change From Baseline in Quality Of life Questionnaire-C30 (QLQ-C30)

    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.

    Measured: 2 years

  7. Number of patients who experienced an adverse event (AE)

    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.

    Measured: 2 years

  8. Duration of the treatment

    Calculated from the date of the first administration of the treatment until the last administration of the last treatment in progress

    Measured: 2 years

  9. Time to treatment discontinuation/failure due to toxicity

    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

    Measured: 2 years

  10. Description of subsequent cancer treatments

    Names of subsequant cancer treatments

    Measured: 2 years

  11. Web-application compliance

    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

    Measured: 2 years

  12. Treatment compliance

    Evaluated by the number of taken tablets verus.the theoretical number of tablets the patient should have taken during a given period

    Measured: 2 years

  13. Sensibility of the application

    Evaluated the number of events diagnosed by the app on the number of events that occurred in total.

    Measured: 2 years

  14. Patient web-application satisfaction

    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

    Measured: 1 year

  15. Performance Status at the end of treatment

    Evaluated with the Eastern Cooperative Oncology Group's recommendations, at each visit

    Measured: 2 years

  16. Medical team web-application satisfaction

    Evaluated with a specific questionnaire at 12 months.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start7 Jun 2021
  3. Primary completion7 Jun 2023 (estimated)
  4. Study completion15 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04764487
Sponsor's protocol ID
WP-2019-03
Other IDs
2020-A01103-36
Acronym
AxiPRO
Status last verified
May 2022
First submitted
8 Feb 2021
Last updated
3 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KidneyPRO and standard follow-up in people with Renal Cell Carcinoma Metastatic, run by Weprom at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Magali BALAVOINE (2 41 68 29 70 ext. +33, m.balavoine@weprom.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

symtom specific Quality Of Life at 24 weeks (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04764487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

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