Clinical trial NCT03013946: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Renal Cell Carcinoma, Metastatic
Renal Cell Cancer, Recurrent
Keywords: Therapy-Coaching, Quality of Life
Lead sponsor: AIO-Studien-gGmbH
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Crolll Gmbh
First posted: 2017-01-09
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility 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 amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with 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 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.
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 (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.

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 \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\].

Primary outcomes:
measure: QoL assessment during sunitinib treatment: questionnaire
timeFrame: 24 weeks from randomization
Secondary outcomes:
measure: Objective Response Rate (ORR) according to RECIST 1.1 criteria
timeFrame: up to one year from randomization
measure: Overall Survival (OS)
timeFrame: up to 36 months from randomization
measure: progression-free survival (PFS)
timeFrame: up to 36 months from randomization
measure: Duration of treatment (coaching and cancer treatment)
timeFrame: Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization
measure: dose density of sunitinib
timeFrame: 24 weeks from randomization
measure: Rate of patients receiving treatment beyond progression
timeFrame: up to 36 months from randomization
measure: Further cancer treatment
timeFrame: up to 36 months
measure: Time to first subsequent therapy (TFST)
timeFrame: up to 36 months
measure: Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):
timeFrame: 24 weeks from randomization
measure: Treatment Emergent Adverse Events according to CTC 4.03:
timeFrame: 24 weeks from randomization
measure: Assessment of comorbidities
timeFrame: at inclusion
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
state: Niedersachsen
city: Stolberg
country: Germany
facility: Hämatologisch-Onkologische Praxis Stolberg
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR)
state: Nordrhein-Westphalen
city: Trier
country: Germany
facility: Krankenhaus Barmherzige Brüder Trier
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R.
state: Sachsen-Anhalt
city: Wittenberg
country: Germany
facility: Urologische Arztpraxis Dr. Ralf Eckert
state: Sachsen-Anhalt
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
city: Berlin
country: Germany
facility: Onkologisches Versorgungszentrum
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Dresden
country: Germany
facility: BAG Onkologische Gemeinschaftspraxis
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie
city: Essen
country: Germany
facility: MVZ für Hämato/Onkologie Essen gGmbH
city: Goslar
country: Germany
facility: MVZ Onkologische Kooperation Harz
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Landshut
country: Germany
facility: Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg 5. Medizinische Klinik
city: Rostock
country: Germany
facility: Wissenschaftskontor Nord GmbH & Co KG
city: Singen
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Soest
country: Germany
facility: MVZ Kloster Paradiese GbR/Onkologiezentrum Soest
Study officials:
affiliation: Universitätsklinikum Essen
name: Viktor Grünwald, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: