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)
