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)

This is an interventional prevention trial for Renal Cell Carcinoma Metastatic focused on measuring Web-application, Quality Of Life, Metastatic renal cell carcinoma, Follow-up, Progression Free Survival, Overall Survival Read More

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