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

AIO-Studien-gGmbH22 sites in 1 country121 target enrollmentJanuary 18, 2017

ConditionsRenal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Renal Cell Carcinoma, Metastatic
Sponsor: AIO-Studien-gGmbH
Enrollment: 121
Locations: 22
Primary Endpoint: QoL assessment during sunitinib treatment: questionnaire
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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 pembrolizumab + axitinib or avelumab + axitinib in first line therapy.

Detailed Description

The goal of our study is to define the benefit of proactive coaching in mRCC, when compared to a reactive approach, which is considered the standard of care. Patients in the Coaching Arm A will be trained continuously at personal interactions of coach and patient (Face-to Face meetings as well as telephone contacts). The patient is educated on nature and severity of treatment emergent Adverse events (TEAE) of sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy. Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and Arm B non Coaching).

Registry

clinicaltrials.gov

Start Date

January 18, 2017

End Date

January 16, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AIO-Studien-gGmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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).

Outcomes

Primary Outcomes

QoL assessment during sunitinib treatment: questionnaire

Time Frame: 24 weeks from randomization

Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.

Secondary Outcomes

Time to first subsequent therapy (TFST)(up to 36 months)
progression-free survival (PFS)(up to 36 months from randomization)
Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):(24 weeks from randomization)
Assessment of comorbidities(at inclusion)
Overall Survival (OS)(up to 36 months from randomization)
Treatment Emergent Adverse Events according to CTC 4.03:(24 weeks from randomization)
Objective Response Rate (ORR) according to RECIST 1.1 criteria(up to one year from randomization)
Duration of treatment (coaching and cancer treatment)(Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization)
Rate of patients receiving treatment beyond progression(up to 36 months from randomization)
dose density of sunitinib(24 weeks from randomization)
Further cancer treatment(up to 36 months)