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 (PREPARE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma, Metastatic; Renal Cell Cancer, Recurrent
• Intervention / Treatment: Behavioral: Concomitant coaching

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).

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Johanna Homfeld; Phone Number: 72 +49 30 8145344; Email: johanna.homfeld@aio-studien-ggmbh.de
• Study Contact Backup: Name: Mischo Kursar, Dr.; Phone Number: 67 +49 30 8145 344; Email: Mischo.Kursar@aio-studien-ggmbh.de

Study Locations

• Germany
  • Amberg, Germany, 92224
    • Recruiting
    • Klinikum St. Marien Amberg
    • Contact: Ludwig Fischer von Weikersthal, Dr.med.
  • Berlin, Germany, 12351
    • Recruiting
    • Vivantes Klinikum Neukölln
    • Contact: Maike de Wit, Prof. Dr.
  • Berlin, Germany, 10407
    • Recruiting
    • Onkologisches Versorgungszentrum
    • Contact: Fritz Maiwirth, Dr.med.
  • Dresden, Germany, 01307
    • Recruiting
    • Universitatsklinikum Carl Gustav Carus Dresden
    • Contact: Manfred Wirth, Prof. Dr.
  • Dresden, Germany, 01307
    • Recruiting
    • BAG Onkologische Gemeinschaftspraxis
    • Contact: Lutz Jacobasch, Dr.med.
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie
    • Contact: Johannes Mohm, Dr. med.
  • Essen, Germany, 45136
    • Not yet recruiting
    • MVZ für Hämato/Onkologie Essen gGmbH
    • Contact: Ulla Frfr. von Verschuer, Dr.
  • Goslar, Germany, 38642
    • Recruiting
    • MVZ Onkologische Kooperation Harz
    • Contact: Mark-Oliver Zahn, Dr.
  • Göttingen, Germany, 37073
    • Not yet recruiting
    • Onkologische Schwerpunktpraxis Göttingen
    • Contact: Michael Metz, Dr.
  • Hannover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover
    • Contact: Philipp Ivanyi, Dr.; Phone Number: 2301 +49 511 532; Email: Ivanyi.Philipp@mh-hannover.de
  • Herzberg, Germany, 37412
    • Not yet recruiting
    • Urologie Herzberg
    • Contact: Thorsten Werner
  • Kaiserslautern, Germany, 67655
    • Not yet recruiting
    • IDGGQ Institut für medizinische Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung
    • Contact: Richard Hansen, Dr. med.
  • Landshut, Germany, 84028
    • Not yet recruiting
    • Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin
    • Contact: Ursula Vehling-Kaiser, Dr. med.
  • Mühlheim, Germany, 45468
    • Not yet recruiting
    • Gemeinschaftspraxis für Hämatologie u. Onkologie PD Dr. Jan Schröder
    • Contact: Jan Schröder, PD Dr.
  • Münster, Germany, 48149
    • Not yet recruiting
    • Universitatsklinikum Munster
    • Contact: Martin Bögemann, PD Dr.
  • Nürnberg, Germany, 90419
    • Recruiting
    • Klinikum Nürnberg 5. Medizinische Klinik
    • Contact: Marinela Augustin, Dr.med.
  • Rostock, Germany, 18107
    • Recruiting
    • Wissenschaftskontor Nord GmbH & Co KG
    • Contact: Andreas Hübner, Dr.
  • Singen, Germany, 78224
    • Recruiting
    • Onkologische Schwerpunktpraxis
    • Contact: Ulrich Banhardt, Dr. med.
  • Soest, Germany, 59494
    • Not yet recruiting
    • MVZ Kloster Paradiese GbR/Onkologiezentrum Soest
    • Contact: Anke Wortmann, Dr.
  • Bayern
    • Regensburg, Bayern, Germany, 93049
      • Recruiting
      • Krankenhaus Barmherzige Bruder Regensburg
      • Contact: Heribert Stauder, MD; Phone Number: 09413693309; Email: heribert.stauder@barmherzige-regensburg.de
      • Contact: heribert.stauder@barmherzige-regensburg.de
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Not yet recruiting
      • Universitatsklinikum Frankfurt
      • Contact: Severine Banek, Dr.; Phone Number: 069 630180072; Email: severine.banek@kgu.de
    • Fulda, Hessen, Germany, 36043
      • Not yet recruiting
      • Klinikum Fulda
      • Contact: Heinz-Gert Höffkes, Prof.; Phone Number: 0926162480; Email: hoeffkes.tumorklinik@klinikum-fulda.de
  • Niedersachsen
    • Göttingen, Niedersachsen, Germany, 37075
      • Not yet recruiting
      • Universitatsmedizin Gottingen
      • Contact: Arne Strauß, Dr.; Phone Number: 055160823; Email: astrauss@med.uni-goettingen.de
  • Nordrhein-Westfalen
    • Stolberg, Nordrhein-Westfalen, Germany, 52222
      • Not yet recruiting
      • Hämatologisch-Onkologische Praxis Stolberg
      • Contact: Matthias Groschek, MD; Email: m.groschek@onkologie-stolberg.de
  • Nordrhein-Westphalen
    • Bonn, Nordrhein-Westphalen, Germany, 53113
      • Not yet recruiting
      • Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus
      • Contact: Yon-Dschun Ko, Prof.; Phone Number: 0228 5432203; Email: yon-dschun.ko@johanniter-kliniken.de
    • Essen, Nordrhein-Westphalen, Germany, 45147
      • Not yet recruiting
      • Universitatsklinikum Essen (Aor)
      • Contact: Viktor Grünwald, Prof.; Phone Number: 0201723-2637; Email: viktor.gruenwald@uk-essen.de
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Not yet recruiting
      • Universitätsmedizin Mainz
      • Contact: Rene Mager, Dr.; Phone Number: 06131172041; Email: rene.mager@unimedizin-mainz.de
    • Trier, Rheinland-Pfalz, Germany, 54292
      • Recruiting
      • Krankenhaus Barmherzige Brüder Trier
      • Contact: Nina Heidger, Dr.; Phone Number: 06512082401; Email: n.heidger@bk-trier.de
  • Sachsen
    • Markkleeberg, Sachsen, Germany, 04416
      • Not yet recruiting
      • Praxis Dr. Schulze
      • Contact: Matthias Schulze, Dr.; Phone Number: 03413542755; Email: info@praxis-schulze.de
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Recruiting
      • Universitätsklinikum Magdeburg A.ö.R.
      • Contact: Andreas Janitzky, Dr.; Phone Number: 03916724770; Email: andreas.janitzky@med.ovgu.de
    • Wittenberg, Sachsen-Anhalt, Germany
      • Not yet recruiting
      • Urologische Arztpraxis Dr. Ralf Eckert
      • Contact: Ralf Eckert, Dr.; Phone Number: 03475250059; Email: urologiestudie.eckert@web.de
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Recruiting
      • Universitätsklinikum Schleswig-Holstein
      • Contact: Nils Gilbert, Dr.; Phone Number: 045150043601; Email: Nils.Gilbert@uksh.de
    • Neumünster, Schleswig-Holstein, Germany, 24534
      • Not yet recruiting
      • FEK - Friedrich-Ebert-Krankenhaus Neumünster
      • Contact: Stefan Mahlmann, Dr.; Phone Number: 043214055037; Email: stefan.mahlmann@fek.de
  • Thüringen
    • Erfurt, Thüringen, Germany, 99097
      • Active, not recruiting
      • Katholisches Krankenhaus St. Johann Nepomuk Erfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (Coaching); Concomitant coaching (24 weeks) Pro-active TEAE (Treatment emergent adverse events) management Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15	Behavioral: Concomitant coaching; The corner stones of the pro-active coaching are as follows: Patient education:Information on nature and severity of treatment emergent AEsinformation about remedies for TEAEspropagation and explanation of tests and treatment decisionsPatient instruction on self-care and preventive measures; Preemptive AE treatment strategies; Supervision of reported ADR severity, ADR mitigation strategies according to recommendations of the PREPARE protocol and cancer treatment modification by treating physician in close collaboration with the coach
No Intervention: Arm B (Control); Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL assessment during sunitinib treatment: questionnaire	Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.	24 weeks from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) according to RECIST 1.1 criteria	Objective Response Rate (ORR) according to RECIST 1.1 criteria	up to one year from randomization
Overall Survival (OS)	Overall Survival (OS)	up to 36 months from randomization
progression-free survival (PFS)	progression-free survival (PFS)	up to 36 months from randomization
Duration of treatment (coaching and cancer treatment)	Duration of treatment (coaching and cancer treatment)	Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization
dose density of sunitinib	dose density of sunitinib	24 weeks from randomization
Rate of patients receiving treatment beyond progression	Rate of patients receiving treatment beyond progression	up to 36 months from randomization
Further cancer treatment	Further cancer treatment	up to 36 months
Time to first subsequent therapy (TFST)	Time to first subsequent therapy (TFST)	up to 36 months
Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):	% of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)	24 weeks from randomization
Treatment Emergent Adverse Events according to CTC 4.03:	Frequency/incidence, severity, percentage reduction, time-to-event of ADRs, AEs and specific TEAEs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension); change of grade 3/4 ADRs	24 weeks from randomization
Assessment of comorbidities	Charlson Comorbidity Index (CCI)	at inclusion

Collaborators and Investigators

• Sponsor: AIO-Studien-gGmbH
• Collaborators: Pfizer; Crolll Gmbh
• Investigators: Principal Investigator: Viktor Grünwald, Prof. Dr., Universitatsklinikum Essen

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Estimated): January 18, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimated): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Therapy-Coaching, Quality of Life
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: AIO-NZK-0115/ass; 2016-000399-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No