A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy
Condition: Renal Cell Carcinoma, Metastatic, Renal Cell Cancer, Recurrent
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03013946
Phase: Phase 3
- Age: minimum 18 Years maximum N/A
- Gender: All
- Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Age ≥ 18 years at time of study entry
- Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib
- Intended first-line treatment with sunitinib
- Documented progressive disease within 6 months prior to study inclusion
- Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.
- Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
- Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.
- Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
- 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].
- CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
- Chronic liver disease with Child-Pugh B or C score
- 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)
- 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
- Participation in another clinical study with an investigational product during the last 30 days before inclusion
- 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
- Previous enrollment or randomization in the present study (does not include screening failure).
- Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
- Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
- 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].
View trial on ClinicalTrials.gov