Actively Recruiting
Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma a Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA
Led by Pierre Fabre Pharma GmbH · Updated on 2021-01-19
750
Participants Needed
59
Research Sites
39 weeks
Total Duration
On this page
Sponsors
P
Pierre Fabre Pharma GmbH
Lead Sponsor
P
Pierre Fabre Pharma Austria
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the real-world use of encorafenib plus binimetinib for patients with unresectable advanced or metastatic melanoma that has a BRAF V600 mutation. This observational study focuses on documenting treatment effects, quality of life, safety, and tolerability after these drugs became commercially available in Germany, Austria, and Switzerland. The study specifically looks at patients treated in the first and second line settings after prior checkpoint inhibitor therapy. The study observes patients who are treated with encorafenib plus binimetinib according to the approved product guidelines. Participants may have started this treatment up to six months before joining the study or may begin treatment soon after enrollment. The study tracks treatment details, effectiveness, side effects, and patient-reported outcomes over a median treatment duration of about 12 months, with a total observation period of up to 90 months. Participants will be followed through regular documentation of their disease and treatment progress, including patient and disease profiles, treatment sequences, adverse events, and quality of life assessments using questionnaires. The main outcome measured is progression-free survival at 12 months after treatment start. Researchers will also evaluate treatment duration, interruptions, dose intensity, and physician satisfaction. Long-term safety and prognostic factors will be monitored throughout the observation period until study completion in September 2027.
CONDITIONS
Brief Title
Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient provides written informed consent for pseudonymized data documentation and transfer
- Male or female patient aged 18 years or older with legal capacity
- Decision to treat with encorafenib plus binimetinib made independently before study inclusion
- Treatment with encorafenib plus binimetinib started within 6 months before consent or planned to start soon
- Diagnosed with unresectable advanced or metastatic malignant melanoma with BRAF V600 mutation
- Treatment-naive or after one prior line of checkpoint inhibitor therapy in advanced or metastatic setting
You will not qualify if you...
- Prior treatment with BRAF and/or MEK inhibitors except adjuvant therapy ended over 6 months before start of encorafenib/binimetinib
- More than one prior line of checkpoint inhibitor treatment in advanced or metastatic setting
- Previous chemotherapy for melanoma
- Any contraindication to encorafenib-binimetinib treatment per product guidelines
- Current or planned participation in an interventional clinical trial
- Current or planned systemic treatment for any tumor other than melanoma
- Prisoners or involuntarily incarcerated persons
Research Team
C
Christian A Rosé, MD
A
Andrea Schmidt, MSc
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