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

Inclusion Criteria:

1. Written informed consent and any locally-required authorization (EU Data PrivacyDirective in the EU) obtained from the subject prior to performing anyprotocol-related procedures, including screening evaluations

2. Age ≥ 18 years at time of study entry

3. Advanced or metastatic renal cell carcinoma, not amendable to surgery with curativeintent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatmentwith sunitinib

4. Intended first-line treatment with sunitinib

5. Documented progressive disease within 6 months prior to study inclusion

6. Patients with measurable disease (at least one uni-dimensionally measurable targetlesion by CT-scan or MRI) according to modified Response Evaluation Criteria inSolid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.

7. Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgeryand palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment andpatient recovered from toxic effects.

8. Female subjects must either be of non-reproductive potential (ie, post-menopausal byhistory: ≥60 years old and no menses for ≥1 year without an alternative medicalcause; OR history of hysterectomy, OR history of bilateral tubal ligation, ORhistory of bilateral oophorectomy) or must have a negative serum pregnancy test uponstudy entry.

9. Subject is willing to receive additional concomitant coaching and able to complywith the QoL/PRO (patient-reported outcome) assessments specified in the protocolfor the duration of the study including scheduled visits, examinations and followup.

Exclusion Criteria:

1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliativeradiotherapy)

2. Previous malignancy (other than mRCC) which either progresses or requires activetreatment. 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 andpatient 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 ofreproductive 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 withevaluation of the concomitant coaching or QoL assessments or interpretation ofpatient safety or study results

7. Participation in another clinical study with an investigational product during thelast 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 thatrelapse occurred at least 6 months after last exposure

9. Previous enrollment or randomization in the present study (does not includescreening failure).

10. Involvement in the planning and/or conduct of the study (applies to both Pfizerstaff and/or staff of sponsor and study site)

11. Patient who might be affiliated or otherwise dependent on the sponsor, site or theinvestigator

12. Patient who has been incarcerated or involuntarily institutionalized by court orderor 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 arational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].