Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Weprom (Voir sur ClinicalTrials)
juin 2021
juin 2025
29 juin 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre François Baclesse - 14076 - Caen - France | FLorence JOLY, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon - France | Sylvie NEGRIER, MD | Contact (sur clinicalTrials) | |||
| CHD Vendée - 85925 - La Roche-sur-Yon - France | Frank PRIOU, MD | Contact (sur clinicalTrials) | |||
| CHP St Grégoire - 35760 - Saint-Grégoire - France | Xavier ARTIGNAN, MD | Contact (sur clinicalTrials) | |||
| CHRU Brest - 29609 - Brest - France | FRIEDERIKE SCHLURMANN, MD | Contact (sur clinicalTrials) | |||
| CHU Bretonneau - 37000 - Tours - France | Berengère NARCISO, MD | Contact (sur clinicalTrials) | |||
| CHU Jean Minjoz - 25000 - Besançon - France | Antoine THIERY-VUILLEMIN, MD | Contact (sur clinicalTrials) | |||
| Clilnique Pasteur - 29000 - Brest - France | Ali HASBINI, MD | Contact (sur clinicalTrials) | |||
| Clinique Victor Hugo / Centre Jean Bernard - 72000 - Le Mans - France | Eric VOOG, MD | Contact (sur clinicalTrials) | |||
| Hôpitaux universitaires de Strasbourg - 67091 - Strasbourg - France | Gabriel MALOUF, MD | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud - 31059 - Toulouse - France | Christine CHEVREAU, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - 49055 - Angers - France | Sophie ABADIE-LACOURTOISIE, MD | Contact (sur clinicalTrials) | |||
| Institut Jean Godinot - 5100 - Reims - France | Jean-Christophe EYMARD, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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