EUCTR2017-002887-42-DE
Active, not recruiting
Phase 1
Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation : an EORTC randomized phase II study (EBIN) - EBI
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- EORTC
- Enrollment
- 270
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Histologically or cytologically confirmed unresectable stage III/ IV
- •cutaneous or mucosal melanoma (unknown primary also allowed)
- •Presence of BRAF V600E or V600K mutation in tumor tissue prior to
- •enrolment as per local assessment
- •Tumor tissue (FFPE) from an unresectable or metastatic site of disease
- •must be provided for biomarker analyses. This can be an archived
- •sample if obtained at maximum 3 months prior to randomization and if
- •the patient did not receive treatment since then.
- •Measurable disease per RECIST 1\.1 criteria by computed tomography
- •(CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis
Exclusion Criteria
- •Uveal melanoma
- •Any symptomatic brain or leptomeningeal disease. Subjects with brain metastases are eligible if these have been locally treated and there is no magnetic resonance imaging (MRI) evidence of progression 4 weeks
- •after end of treatment. There must also be no requirement for
- •immunosuppressive doses of systemic corticosteroids (\> 10 mg/day
- •prednisone equivalents) for at least 2 weeks prior to study drug
- •administration.
- •Any prior treatment for advanced disease including treatment with an
- •anti\-programmed death receptor\-1 (PD\-1\), anti\-programmed death\-1
- •ligand\-1 (PD\-L1\), anti\-PD\-L2, anti\-cytotoxic T lymphocyte associated
- •antigen\-4 (anti\-CTLA\-4\) antibody, anti\-LAG\-3, anti\-TIM\-3, anti\-IDO, etc
Investigators
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