EUCTR2017-002887-42-GB
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
European Organisation for Research and Treatment of Cancer0 sites270 target enrollmentStarted: March 7, 2018Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- European Organisation for Research and Treatment of Cancer
- 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
- •Presence of BRAF V600E or V600K mutation in tumor tissue prior to enrolment as per local assessment
- •Tumor tissue 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 and brain CT/MRI performed within 28 days prior to randomization
- •Patients \= 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Patients must be able to swallow and retain oral tablets
- •Adequate organ function within 14 days prior to randomization:
- •Absolute neutrophil count (ANC) \= 1\.5 x 109/L (\= 1500 per mm3\)
- •Lymphocyte count \= 1\.0 x 109/L (\= 1000 per mm3\)
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 or BRAF or MEK inhibitors.
- •History of hypersensitivity to study drugs or any excipient (refer to Investigator's brochures for binimetinib and encorafenib and SmPCs for ipilimumab and nivolumab).
- •Prior adjuvant melanoma therapy with IFN, anti\-PD1, anti\-PDL1 or anti\-CTLA\-4 or any other systemic treatment is permitted if completed at least 1 year prior to randomization and all related adverse events have returned to grade \= 1\.
- •Concomitant administration of strong inducers and inhibitors of P\-gp, glucuronidation, CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John’s Wort \[hypericin])
- •Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin)
- •Live vaccines within 30 days prior to the first dose of study therapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine.
- •Current participation or treatment with other investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment
- •Child\-Pugh B/C and patients with history of acute or chronic pancreatitis
Investigators
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