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

Renal Cell Carcinoma, Metastatic Clinical Trial

— PREPARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013946
• Other study ID #: AIO-NZK-0115/ass
• Secondary ID: 2016-000399-28
• Status: Recruiting
• Phase: Phase 3
• Start date: January 18, 2017
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2023
• Source: AIO-Studien-gGmbH
• Contact: Mischo Kursar, Dr.
• Phone: +49 30 8145 344
• Email: Mischo.Kursar[@]aio-studien-ggmbh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: July 31, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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].

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Cancer, Recurrent
• Renal Cell Carcinoma, Metastatic

Intervention

Behavioral:
• Concomitant coaching
The corner stones of the pro-active coaching are as follows: Patient education: Information on nature and severity of treatment emergent AEs information about remedies for TEAEs propagation and explanation of tests and treatment decisions Patient 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

Locations

Country	Name	City	State
Germany	Klinikum St. Marien Amberg	Amberg
Germany	Onkologisches Versorgungszentrum	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Evangelische Kliniken Bonn gGmbH, Johanniter Krankenhaus	Bonn	Nordrhein-Westphalen
Germany	BAG Onkologische Gemeinschaftspraxis	Dresden
Germany	Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange Krex Fachärzte für Innere Medizin Hämatologie und Internistische Onkologie	Dresden
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Katholisches Krankenhaus St. Johann Nepomuk Erfurt	Erfurt	Thüringen
Germany	MVZ für Hämato/Onkologie Essen gGmbH	Essen
Germany	Universitätsklinikum Essen (AöR)	Essen	Nordrhein-Westphalen
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main	Hessen
Germany	Klinikum Fulda	Fulda	Hessen
Germany	MVZ Onkologische Kooperation Harz	Goslar
Germany	Onkologische Schwerpunktpraxis Göttingen	Göttingen
Germany	Universitätsmedizin Göttingen	Göttingen	Niedersachsen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Urologie Herzberg	Herzberg
Germany	IDGGQ Institut für medizinische Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung	Kaiserslautern
Germany	Tagesklinik Landshut Hämatologie, Onkologie Palliativmedizin	Landshut
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Universitätsklinikum Magdeburg A.ö.R.	Magdeburg	Sachsen-Anhalt
Germany	Universitätsmedizin Mainz	Mainz	Rheinland-Pfalz
Germany	Praxis Dr. Schulze	Markkleeberg	Sachsen
Germany	Gemeinschaftspraxis für Hämatologie u. Onkologie PD Dr. Jan Schröder	Mühlheim
Germany	Universitätsklinikum Münster	Münster
Germany	FEK - Friedrich-Ebert-Krankenhaus Neumünster	Neumünster	Schleswig-Holstein
Germany	Klinikum Nürnberg 5. Medizinische Klinik	Nürnberg
Germany	Krankenhaus Barmherzige Brüder Regensburg	Regensburg	Bayern
Germany	Wissenschaftskontor Nord GmbH & Co KG	Rostock
Germany	Onkologische Schwerpunktpraxis	Singen
Germany	MVZ Kloster Paradiese GbR/Onkologiezentrum Soest	Soest
Germany	Hämatologisch-Onkologische Praxis Stolberg	Stolberg	Nordrhein-Westfalen
Germany	Krankenhaus Barmherzige Brüder Trier	Trier	Rheinland-Pfalz
Germany	Urologische Arztpraxis Dr. Ralf Eckert	Wittenberg	Sachsen-Anhalt

Sponsors (3)

Lead Sponsor	Collaborator
AIO-Studien-gGmbH	Crolll Gmbh, Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival (OS)	Overall Survival (OS)	up to 36 months from randomization
Secondary	progression-free survival (PFS)	progression-free survival (PFS)	up to 36 months from randomization
Secondary	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
Secondary	dose density of sunitinib	dose density of sunitinib	24 weeks from randomization
Secondary	Rate of patients receiving treatment beyond progression	Rate of patients receiving treatment beyond progression	up to 36 months from randomization
Secondary	Further cancer treatment	Further cancer treatment	up to 36 months
Secondary	Time to first subsequent therapy (TFST)	Time to first subsequent therapy (TFST)	up to 36 months
Secondary	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
Secondary	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
Secondary	Assessment of comorbidities	Charlson Comorbidity Index (CCI)	at inclusion