drugset / Trial / NCT01940809

Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery

NCT01940809

Phase 1 Terminated 15 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating melanoma.

Timeline

Start
2013-08-28
Primary completion
2020-07-17
Completion
2022-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule Oral
Subject Ipilimumab Monoclonal antibody Intravenous
Subject Nivolumab Monoclonal antibody Intravenous
Subject Trametinib Small molecule Oral