Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Melanoma (Skin)
- Skin Cancer
- Skin Carcinoma
- Skin Melanoma
- Type
- Interventional
- Phase
- Early 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
Vemurafenib and cobimetinib are already U.S. Food and Drug Administration (FDA)-approved for the treatment of BRAF-mutant metastatic melanoma; however, melanoma often develops resistance to these drugs over time, and the tumors start to re-grow. Investigators will use the participant's LDH (lactate ...
Vemurafenib and cobimetinib are already U.S. Food and Drug Administration (FDA)-approved for the treatment of BRAF-mutant metastatic melanoma; however, melanoma often develops resistance to these drugs over time, and the tumors start to re-grow. Investigators will use the participant's LDH (lactate dehydrogenase) levels obtained from routine blood work, along with CT scans to decide when to hold or resume their study treatment. Investigators hypothesize that this type of dosing schedule with vemurafenib and cobimetinib may potentially delay the time to progression and re-growth of their melanoma.
Tracking Information
- NCT #
- NCT03543969
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zeynep Eroglu, M.D. H. Lee Moffitt Cancer Center and Research Institute