Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Melanoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This research study is a Phase I clinical trial, which tests the safety of the investigational drugs and also tries to define the appropriate doses of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Admin...

This research study is a Phase I clinical trial, which tests the safety of the investigational drugs and also tries to define the appropriate doses of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Administration) has not approved itacitinib as a treatment for any disease. The FDA has approved dabrafenib and trametinib as a treatment option for Melanoma. In this research study, the investigators are studying the combination of itacitinib, dabrafenib, and trametinib. The investigators believe this combination of study drugs may stop the participant's cancer cells from growing and spreading. All three of the study drugs are inhibitors. Trametinib may work by binding to the participant's cancer cells to inhibit the cancer cells' signals to decrease cell growth, dabrafenib may work by stopping the participant's cancer cells from duplicating, and itacitinib may work by stopping the participant's tumor cells from living and growing.

Tracking Information

NCT #
NCT03272464
Collaborators
Incyte Corporation
Investigators
Principal Investigator: Keith T. Flaherty, MD Massachusetts General Hospital