Cancer Type: Cutaneous
Study Type: Treatment
Phase: Early Phase I
Principal Investigator: Eroglu, Zeynep
Pilot Study of Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma
This is a pilot study evaluating the feasibility of using adaptive intermittent dosing of vemurafenib and cobimetinib in BRAF mutant patients with elevated baseline lactate dehydrogenase (LDH). The purpose of this study is to determine whether an intermittent adaptive dosing of vemurafenib and cobimetinib may be superior to standard, continuous dosing with these study drugs.
Primary Objective: Determine feasibility of an adaptive intermittent treatment design, as defined by how many patients successfully reach 16 weeks with the prescribed on/off schedule without progression of disease. Secondary Objectives: Estimate time to treatment failure, defined as the time from the day of first dose of study drugs to the first day of treatment with another regimen or with the same regimen in a non-adaptive fashion. Estimate objective tumor response rate. Assess toxicity and dose delivery, both over the entire course of therapy and on a per day basis. Perform single cell analyses in tumor biopsies and measure BRAF cfDNA in serial plasma samples.
Chemotherapy (NOS); Immunotherapy; Therapy (NOS)
BMS-936558 (Nivolumab); Binimetinib (); Cobimetinib (); Encorafenib (); Nivolumab (Opdivo); Not Applicable (); RO5185426 (Vemurafenib); Vemurafenib (Zelboraf)
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub
Our patient services specialists can assist you with scheduling an appointment, questions about medical records, insurance, billing and more.
Patient Appointment Center Hours: 7 a.m. to 7 p.m. Monday - Friday; 8 a.m. to noon Saturday