Dienstag, 2. März 2021
Navigation öffnen
Anzeige:
Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

BERING Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Rekrutierend

NCT-Nummer:
NCT04045691

Studienbeginn:
Oktober 2019

Letztes Update:
19.01.2021

Wirkstoff:
Encorafenib, Binimetinib

Indikation (Clinical Trials):
Melanoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Pierre Fabre Pharma GmbH

Collaborator:
Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG,

Kontakt

Studienlocations (3 von 59)

Darmzentrum Portal10 Münster
Albersloher Weg 10
48153 Münster
DeutschlandRekrutierend» Google-Maps
Darmzentrum Portal10 Münster
Albersloher Weg 10
48153 Münster
DeutschlandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study -

investigates real-world effectiveness, quality of life, safety and tolerability of

encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated

Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these

two products in Germany, Austria and Switzerland. The study focusses on the documentation of

the first and second line setting (i.e. after one line of prior checkpoint inhibition) by

documenting patients treated according to the SmPC (Summary of Product Characteristics).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Written informed consent of the patient with regard to the pseudonymized documentation

as well as the transfer and processing of his/her data within the study and the ADOREG

[Cancer Registry of German Working Group of Dermato-Oncology] registry (data transfer

to ADOREG registry only for patients from German sites);

- Legally capable male or female patient ≥ 18 years of age (no upper limit);

- Decision was taken to treat the patient with encorafenib plus binimetinib in

accordance with the current SmPC [Summary of Product Characteristics] and by

prescription; this decision was taken prior to and independent from the inclusion into

the study;

- Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior to

providing written informed consent for this study or is planned to be started in the

near future;

- Unresectable advanced or metastatic malignant melanoma with BRAF [Rapidly Accelerated

Fibrosarcoma isoform B] V600 mutation;

- Treatment-naive or after one prior line of checkpoint inhibitor treatment (anti-CTLA4

[Cytotoxic T-Lymphocyte Antigen-4] and/or anti-PD(L)1 [Programmed cell Death protein

1]) in the unresectable advanced or metastatic setting.

Exclusion Criteria:

- Previous treatment with a BRAF- and/or MEK [Mitogen-Activated

Protein/Extracellular-signal Regulated Kinase]- inhibitor except for:

-- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended > 6

months prior start of Encorafenib/Binimetinib treatment;

- More than one prior line of checkpoint inhibitor treatment in the unresectable

advanced or metastatic setting;

- Any previous chemotherapeutic treatment of the melanoma disease;

- Presence of any contraindication with regard to the encorafenib-binimetinib-treatment

as specified in the corresponding SmPCs;

- Current or upcoming participation in an interventional clinical trial;

- Current or upcoming systemic treatment of any other tumor than melanoma;

- Prisoners or persons who are compulsorily detained (involuntarily incarcerated).

Studien-Rationale

Primary outcome:

1. Progression-free survival (Time Frame - At 12 months after start of treatment):
Progression-free survival rate



Secondary outcome:

1. Patient and disease profiles at start of treatment with encorafenib plus binimetinib (Time Frame - Baseline):
Demographic and disease characteristics

2. Type of treatments before and after encorafenib plus binimetinib (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
Treatment sequence prior to and after encorafenib plus binimetinib; by documenting pre-treatments with adjuvant therapy and systemic therapy in palliative setting; and by documenting subsequent systemic treatment lines after administration of encorafenib plus binimetinib

3. Sequence of treatments before and after encorafenib plus binimetinib (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
Treatment sequence prior to and after encorafenib plus binimetinib; by documenting pre-treatments with adjuvant therapy and systemic therapy in palliative setting; and by documenting subsequent systemic treatment lines after administration of encorafenib plus binimetinib

4. Characteristics of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Evaluation of reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)

5. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Further progression-free survival parameters

6. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Time-to-progression

7. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Best observed tumor response

8. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Overall response rate

9. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Duration of response

10. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Disease control rate

11. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Duration of disease control

12. Effectiveness of treatment with encorafenib plus binimetinib (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
Overall survival

13. Patient reported outcomes during treatment with encorafenib plus binimetinib - evaluated with EORTC QLQ C-30 (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
EORTC QLQ C-30 questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life C-30 questionnaires) to assess quality of life of cancer patients; comprises 30 items, 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms.

14. Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with WPAI (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
WPAI questionnaires (Work Productivity and Activity Impairment questionnaires). The following questions ask about the effect of patients melanoma on the ability to work and perform regular activities. Are you currently employed (working for pay)? During the past seven days, how many hours did you miss from work because of problems associated with your melanoma? During the past seven days, how many hours did you miss from work because of any other reason? During the past seven days, how many hours did you actually work? During the past seven days, how much did your melanoma affect your productivity while you were working? During the past seven days, how much did your melanoma affect your ability to do your regular daily activities, other than work at a job?

15. Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with CTSQ (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
CTSQ questionnaires (Cancer Therapy Satisfaction Questionnaire) to assess patients' opinions and feelings concerning their cancer therapy and associated adverse events: Questions to patients thoughts about cancer therapy (IV/pills). Scale: [Always, Most of the time, Some-times, Rarely, Never]; Questions to patients satisfaction with the most recent cancer therapy (IV/pills): Scale reg. benefit: [Much better than my expectations Somewhat better than my expectations, Met my expectations, Somewhat worse than my expectations, Much worse than my expectations]; Scale reg. side effects: [Much better than I expected, Somewhat better than I expected, Exactly as I expected, Somewhat worse than I expected, Much worse than I expected]; Scale reg. satisfaction: [Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, Very dissatisfied]; Scale reg. choice of therapy: [Yes, definitely, Probably Yes, I don't know, Probably not, Definitely not]

16. Physicians' satisfaction with regard the treatment with encorafenib plus binimetinib (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
Physicians' satisfaction questionnaires (measuring Physician's Satisfaction with regard to Effictiveness and Safety, as well as Physician's Overall Treatment Satisfaction) using the following scale construct: Physician's Satisfaction with regard to Efficiency Physician's Satisfaction with regard to Safety Physician's Overall Treatment Satisfaction Scale: very dissatisfied dissatisfied moderately satisfied satisfied very satisfied

17. Safety and tolerability of treatment with encorafenib plus binimetinib - Adverse events and adverse reactions including time to onset and time to resolution (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
Number of patients with Adverse Events and maximum grade per patient, Adverse Drug Reactions, Adverse Drug Reactions grade 3/4, Serious Adverse Events, Serious Adverse Drug Reactions.

18. Prognostic factors (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
Influence of prognostic factors on quality of life outcome parameters

19. Prognostic factors (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
Influence of prognostic factors on effectiveness

20. Prognostic factors (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
Influence of prognostic factors on safety

21. Treatment duration (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)

22. Treatment dose intensity (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)

23. Number of treatment interruptions (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)

24. Duration of treatment interruptions (Time Frame - From start to end of treatment (anticipated median treatment duration ca. 12 months)):
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)

Geprüfte Regime

  • Encorafenib:
    Observation of real-life treatment with encorafenib and binimetinib
  • Binimetinib:
    Observation of real-life treatment with encorafenib and binimetinib

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren

Fortschritte durch hoch spezialisierte Medikamente

Analysenroboter, Hochleistungs-Computer, modernste Labore, Kreativität und enorme Forschungsgelder - es müssen viele Faktoren zusammenkommen, damit ein neues Medikament auf den Markt kommen kann. Die Suche nach neuen Wirkstoffen setzt bei der Krankheit an: Gibt es bestimmte Botenstoffe, Enzyme oder Hormone, die zum Beispiel bei einem bestimmten Tumor das Krebswachstum antreiben? Oder spielen bestimmte Strukturen auf der Zelloberfläche eine Rolle, sogenannte Rezeptoren,...

Brustkrebsmonat: Antihormonelle Therapie mit Nebenwirkungen

Brustkrebsmonat: Antihormonelle Therapie mit Nebenwirkungen
© LIGHTFIELD STUDIOS - stock.adobe.com

Etwa zwei Drittel aller bösartigen Brusttumore wachsen hormonabhängig. Weibliche Hormone wie das Östrogen lösen in den Tumorzellen einen Wachstumsreiz aus. Um das zu verhindern und das Rückfallrisiko zu senken, erhalten viele Brustkrebspatientinnen nach einer Operation zur Entfernung des Tumors über mehrere Jahre eine antihormonelle Therapie. Experten stufen die Begleiterscheinungen der Therapie zwar als weniger gravierend als bei einer Chemotherapie ein, viele...

Hufeland-Preis ehrt Initiatoren eines bundesweiten Kita-Sonnenschutzprojekts zur Krebsprävention

Hufeland-Preis ehrt Initiatoren eines bundesweiten Kita-Sonnenschutzprojekts zur Krebsprävention
© drubig-photo / Fotolia.com

Prof. Eckhard Breitbart, Vorsitzender der Arbeitsgemeinschaft für Dermatologische Prävention e.V. (ADP), Dr. Nadja Seidel und Dr. Friederike Stölzel, Leiterinnen des Präventionszentrums des Nationalen Centrums für Tumorerkrankungen Dresden (NCT/UCC) sind mit dem Hufeland-Preis des Kuratoriums der Stiftung Hufeland-Preis ausgezeichnet worden. Sie erhielten den mit 20.000 Euro dotierten Preis für Präventivmedizin für ihr bundesweites Sonnenschutz-Projekt...