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

Phase 3 Active, not recruiting NCT02224781

Summary

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

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

• A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration — National Cancer Institute (NCI)
• Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-I — National Cancer Institute (NCI)
• Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With — Bristol-Myers Squibb
• Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Select — National Cancer Institute (NCI)
• Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, — National Cancer Institute (NCI)
• Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Me — National Cancer Institute (NCI)

All trials