advanced or metastatic renal cell carcinoma MedDRA version: 21.1 Level: PT Classification code 10038414 Term: Renal cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SUTENT 12,5 mg Hartkapseln
Product Name: Sunitinib
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB
CAS Number: 557795-19-4
Concentration unit: mg milligram(s)
Concentrati
Sponsors
AIO-Studien-gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 2. Age = 18 years at time of study entry 3. Advanced or metastatic renal cell carcinoma, not amenable to surgery with curative intent, rendering the patient eligible for 1st line systemic treatment 4. Intended first-line treatment with sunitinib, with pembrolizumab plus axitinib or with avelumab plus axitinib 5. Documented progressive disease within 6 months prior to study inclusion 6. 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) and non-measurable disease are eligible. 7. 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. 8. 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. 9. Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. Any other anti-cancer treatment aside of sunitinib, axitinib, pembrolizumab and avelumab 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 or immune checkpoint 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].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to determine the effect of a 24-week concomitant coaching on patient reported outcomes of patients receiving standard treatment for mRCC with sunitinib or a combination of axitinib + checkpoint inhibitor (CPI). ;Secondary Objective: Assessment of the impact of a 24 weeks concomitant coaching on additional QoL measures, patient compliance, efficacy and safety;Primary end point(s): QoL assessment during SOC 1st-line treatment: Rate of responders to concomitant coaching assessed by the FKSI-15 questionnaire. ;Timepoint(s) of evaluation of this end point: HR-QoL assessments are to be performed at baseline (before treatment within the study), at week 4 (day 28), week 6 (day) and week 10 of therapy. From thereon HR-QoL assessments will be performed every 6 weeks. A final HR-QoL assessment will be performed at discontinuation of therapy or after 24 weeks (end of coaching), whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • ORR according to RECIST 1.1 criteria • OS • PFS • Duration of treatment • dose density of SOC 1st line treatment • rate of hospitalization irrespective of TEAEs • Treatment beyond progression • Further cancer treatment and time to first subsequent therapy (TFST) • Patient adherence / drug-related treatment discontinuation rates: – percentage of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension) • Treatment Emergent Adverse Events according to CTC 4.03: – Frequency/incidence, severity, percentage reduction, time-to-event of ADRs, SAEs and specific TEAEs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension) – reduction of grade 3/4 ADRs • Health related Quality of Life (FACT-G, EQ-5D) – Time to improvement or deterioration measured by HR-QoL • Assessment of comorbidities by Charlson Comorbidity Index (CCI) and social status ;Timepoint(s) of evaluation of this end point: The radiological evaluation of tumor progression lies at the discretion of the investigator. ORR, OS, PFS, duration of treatment, hospitalization rate, TSFT, will be calculated as defined in the protocol. Treatment-emergent AEs will be assessed according to NCI CTCAE v4.03 criteria continuously during study conduct. | — |
Countries
Germany
Contacts
Public ContactAIO-Studien-gGmbH
AIO-Studien-gGmbH
Outcome results
None listed