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

NCT04764487 | Unknown Phase 3 DMC

• 2 other identifiers: WP-2019-032020-A01103-36
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 13

Brief 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 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.

Conditions

Renal Cell Carcinoma Metastatic

Keywords

Web-application; Quality Of Life; Metastatic renal cell carcinoma; Follow-up; Progression Free Survival; Overall Survival

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (16)

• Overall survival

  2 years

• Progression Free survival

  2 years

• Treatment Free Survival

  2 years

• Duration Of Response

  2 years

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

  2 years

Study Arms (2)

Standard follow-up

OTHER

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

KidneyPRO web-application follow up

EXPERIMENTAL

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

Interventions

KidneyPRO DEVICE

Web-application for symptoms assessment

Also known as: web-application

KidneyPRO web-application follow up

standard follow-up OTHER

usual follow-up

Standard follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Weprom: lead
• Pfizer: collaborator
• FLGXPL: collaborator

Study Sites (13)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

NOT YET RECRUITING

CHU Jean Minjoz

Besançon, 25000, France

NOT YET RECRUITING

Clilnique Pasteur

Brest, 29000, France

RECRUITING

CHRU Brest

Brest, 29609, France

NOT YET RECRUITING

Centre François Baclesse

Caen, 14076, France

NOT YET RECRUITING

CHD Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, 72000, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

NOT YET RECRUITING

Institut Jean Godinot

Reims, 5100, France

RECRUITING

CHP St Grégoire

Saint-Grégoire, 35760, France

RECRUITING

Hôpitaux universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31059, France

NOT YET RECRUITING

CHU Bretonneau

Tours, 37000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; 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

Study Officials

• Eric VOOG, MD

  Clinique Victor Hugo/Centre Jean Bernard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali BALAVOINE

CONTACT

2 41 68 29 70; m.balavoine@weprom.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 21, 2021
• Study Start: June 7, 2021
• Primary Completion: June 7, 2023
• Study Completion: June 15, 2025
• Last Updated: May 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)