Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy

Exclusion Criteria

• •1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
• •2. Previous malignancy (other than mRCC) which either progresses or requires active treatment.
• •Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor \[Ta, Tis and T1\].
• •3. CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
• •4. Chronic liver disease with Child-Pugh B or C score
• •5. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
• •6. Any condition that, in the opinion of the investigator, would interfere with evaluation of the concomitant coaching or QoL assessments or interpretation of patient safety or study results
• •7. Participation in another clinical study with an investigational product during the last 30 days before inclusion
• •8. Any previous treatment with a tyrosine kinase inhibitor for metastatic disease. Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that relapse occurred at least 6 months after last exposure
• •9. Previous enrollment or randomization in the present study (does not include screening failure).
• •10. Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
• •11. Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
• •12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities \[§ 40 Abs. 1 S. 3 Nr. 4 AMG\].
• •13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\].