NCT04045691 Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
| NCT ID | NCT04045691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pierre Fabre Pharma GmbH |
| Condition | Melanoma Stage IV |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2019-10-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2019-10-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04045691 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma Stage IV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04045691 currently recruiting?
Yes, NCT04045691 is actively recruiting participants. Contact the research team at bering_de@pierre-fabre.com for enrollment information.
Where is the NCT04045691 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Klagenfurt, Austria, Linz, Austria and 11 additional locations.
Who is sponsoring the NCT04045691 clinical trial?
NCT04045691 is sponsored by Pierre Fabre Pharma GmbH. The trial plans to enroll 750 participants.
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