This research study is studying a combination of drugs as a possible treatment for BRAF-mutant melanoma. The drugs involved in this study are: - Itacitinib (INCB039110) - Dabrafenib - Trametinib
Name: Trametinib
Name: Dabrafenib
Name: INCB039110
Description: Doses at which fewer than one third of patients have severe toxicity
Measure: Maximum Tolerated Dose Time: 2 yearsDescription: Proportion of patients with tumor shrinkage that meets standard criteria for response
Measure: Objective Response Rate Time: 2 yearsDescription: Time until worsening of cancer
Measure: Progression Free Survival Time: 6 MonthsDescription: Time until death from cancer
Measure: Overall Survival Time: 1 yearDescription: Proportion of patients with complete tumor shrinkage
Measure: Complete response rate Time: 2 yearsDescription: Proportion of patients with less than complete tumor shrinkage
Measure: Partial Response Rate Time: 2 yearsDescription: Proportion of patients with no change in tumor size
Measure: Stable Disease Time: 2 yearsDescription: Proportion of patients with worsening of cancer at or before first response assessment
Measure: Progressive Disease Time: 2 yearsAllocation: N/A
Single Group Assignment
There is one SNP
Inclusion Criteria: - For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective. --- V600E ---
- For Dose-Expansion Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy at full dose or not previously received BRAF targeted therapy. --- V600E ---
Current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded Inclusion Criteria: - For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective. --- V600E ---