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

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ClinicalTrials.gov Identifier: NCT04045691
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
Pierre Fabre Pharma Austria
Pierre Fabre Pharma AG
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH

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).

Condition or disease Intervention/treatment
Melanoma Stage IV Melanoma Stage III Drug: Encorafenib Drug: Binimetinib

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma: a Multi-centric, Multinational, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma


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


Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: At 12 months after start of treatment ]
    Progression-free survival rate


Secondary Outcome Measures :
  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.

    1. Are you currently employed (working for pay)?
    2. During the past seven days, how many hours did you miss from work because of problems associated with your melanoma?
    3. During the past seven days, how many hours did you miss from work because of any other reason?
    4. During the past seven days, how many hours did you actually work?
    5. During the past seven days, how much did your melanoma affect your productivity while you were working?
    6. 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:

    1. Questions to patients thoughts about cancer therapy (IV/pills). Scale: [Always, Most of the time, Some-times, Rarely, Never];
    2. Questions to patients satisfaction with the most recent cancer therapy (IV/pills):

      1. 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];
      2. 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];
      3. Scale reg. satisfaction: [Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, Very dissatisfied];
      4. 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:

    1. Physician's Satisfaction with regard to Efficiency
    2. Physician's Satisfaction with regard to Safety
    3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with unresectable advanced or metastatic BRAFV600-mutant malignant melanoma, with a decision to receive targeted treatment with Encorafenib/Binimetinib according to the current SmPC.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045691


Contacts
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Contact: Christian A Rosé, MD +49 761 45261 ext 0 bering_de@pierre-fabre.com
Contact: Andrea Schmidt, MSc +49 641 94436 ext 0 ansc@alcedis.de

Locations
Show Show 59 study locations
Sponsors and Collaborators
Pierre Fabre Pharma GmbH
Pierre Fabre Pharma Austria
Pierre Fabre Pharma AG
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Responsible Party: Pierre Fabre Pharma GmbH
ClinicalTrials.gov Identifier: NCT04045691    
Other Study ID Numbers: NIS-PFO-2019-1921
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Fabre Pharma GmbH:
BERING
Encorafenib
Binimetinib
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas