BENITIONSClinical Trial Intelligence

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

3상 진행 중(모집 완료) NCT02224781

대상 질환Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Recurrent Melanoma
임상 단계3상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수267 명
중재(약물)Biospecimen Collection, Computed Tomography, Dabrafenib Mesylate, Echocardiography Test, Ipilimumab
시작일2015년 9월 8일
완료일2023년 9월 30일
결과 공개일2026년 2월 18일

요약

This phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

2-year Overall Survival (OS)

assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry · Proportion of participants

Arm A (Immunotherapy)0.683 Proportion of participants
Arm B (BRAF Inhibitor Therapy)0.541 Proportion of participants
p-value0.002

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