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4-year survival and biomarkers evaluation from a phase II study of sequential immunotherapy and targeted therapy for metastatic BRAF V600-mutated melanoma

ABSTRACT: SECOMBIT is a randomized, three-arm, noncomparative phase II trial (ClinicalTrials.gov identifier: NCT02631447). Patients with untreated, metastatic BRAFV600-mutant melanoma from 37 sites in nine countries were randomly assigned to arm A (encorafenib [450 mg orally once daily] plus binimetinib [45 mg orally twice daily] until progressive disease [PD] -> ipilimumab plus nivolumab [ipilimumab 3 mg/kg once every 3 weeks and nivolumab 1 mg/kg once every 3 weeks ? four cycles -> nivolumab 3 mg/kg every 2 weeks]), arm B [ipilimumab plus nivolumab until PD -> encorafenib plus binimetinib], or arm C (encorafenib plus binimetinib for 8 weeks -> ipilimumab plus nivolumab until PD -> encorafenib plus binimetinib). The primary end point was overall survival (OS) at 2 years. Secondary end points included total progression-free survival, 3-year OS, best overall response rate, duration of response, and biomarkers in the intent-to-treat population.

INSTRUMENT(S): Ion S5XL

ORGANISM(S): Homo Sapiens

SUBMITTER: IRCCS Pascale

PROVIDER: PRJEB70957 | EVA | 2023-12-12

REPOSITORIES: EVA

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			Action	DRS
	ELOAD_1226_NGS_Analysis_merged.vcf.csi	Other
	ELOAD_1226_NGS_Analysis_merged.vcf.gz	Vcf
	ELOAD_1226_NGS_Analysis_merged.vcf.gz.csi	Vcf

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4-year survival and biomarkers evaluation from a phase II study of sequential immunotherapy and targeted therapy for metastatic BRAF V600-mutated melanoma

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