BRAF V600E Mutation Present Clinical Trial
Official title:
Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To determine the activity of BRAF and MEK inhibitor combination in untreated papillary craniopharyngiomas as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment. II. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas that have progressed after prior radiation treatment with or without surgical resection as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment. SECONDARY OBJECTIVES: I. To determine the progression-free survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors. II. To determine the toxicity of BRAF/MEK inhibitors in patients with papillary craniopharyngiomas. III. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma. IV. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma. V. To determine the overall survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors. VI. To determine the duration of response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors. TERTIARY OBJECTIVES: I. To evaluate visual fields in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors. II. To evaluate pituitary hormone replacement over time in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors. III. To evaluate the time to response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors. IV. To assess toxicity that may be associated with radiotherapy in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors. V. To evaluate molecular biomarkers of response in papillary craniopharyngiomas. VI. To evaluate circulating tumor cells and cell-free circulating deoxyribonucleic acid (DNA) in patients with papillary craniopharyngiomas. OUTLINE: Patients receive vemurafenib orally (PO) twice daily (BID) on day 1-28 and cobimetinib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive radiation therapy, surgery, or continued treatment with vemurafenib and cobimetinib at the discretion of the treating physician. After completion of study treatment, patients with disease progression are followed up every 16 weeks for 2 years and all other patients are followed up every 6 months for 5 years. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04061980 -
Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02097225 -
Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Terminated |
NCT01940809 -
Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery
|
Phase 1 |