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Web-based follow-up for advanced renal cell carcinoma patients treated with axitinib and pembrolizumab

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

Phase 3 Interventional Weprom · NCT04764487

This study is testing a new web app called KidneyPRO to see if it helps patients with advanced kidney cancer who are being treated with axitinib and pembrolizumab manage their symptoms better than regular follow-up methods.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment178 (estimated)
Ages18 Years and up
SexAll
SponsorWeprom Academic / other
Drugs / interventionspembrolizumab, ipilimumab, axitinib, immunotherapy, radiation, prednisone, Sunitinib, chemotherapy
Locations13 sites (Angers and 12 other locations)
Trial IDNCT04764487 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a web application called KidneyPRO for monitoring patients with advanced renal cell carcinoma who are receiving first-line treatment with axitinib and pembrolizumab. The study aims to compare this web-mediated follow-up approach to standard follow-up methods, focusing on improving patient management and quality of life. Patients will self-assess their symptoms weekly through the application, allowing for early detection of complications or recurrences. The trial seeks to optimize treatment adherence and reduce resource use while maintaining continuous patient-provider communication.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced renal cell carcinoma requiring first-line treatment with axitinib and pembrolizumab.

Not a fit: Patients with ECOG Performance Status of 3 or higher or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance patient monitoring and improve treatment outcomes for those with advanced renal cell carcinoma.

How similar studies have performed: Other studies have shown promising results with web-based monitoring approaches in cancer care, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Angers and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Renal Cell Carcinoma MetastaticWeb-applicationQuality Of LifeMetastatic renal cell carcinomaFollow-upProgression Free SurvivalOverall Survival
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.