Highlights of the NCCN Oncology Research Program
The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.
NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.
NCCN-sponsored studies funded through the grant mechanism are highlighted below.
Biomarkers of Response and Resistance to Sequential B-RAF and MEK Targeted Therapy in a Presurgical Model of Advanced, Operable Melanoma
Principal Investigator: Mark Kelley, MD, MMHC, FACS
Condition: Melanoma
Institution: Vanderbilt-Ingram Cancer Center
The purpose of this study is to identify biomarkers of response and resistance to B-RAF and MEK targeted therapy in melanoma. Twenty patients with advanced, operable B-RAF mutation-positive melanoma will receive dabrafenib for 2 weeks, followed by the combination of dabrafenib and trametinib for 2 weeks, followed by surgical resection of the disease. Tumor biopsies will be obtained before initiation of therapy, after 2 weeks of dabrafenib, and at the time of surgery after 2 weeks of dabrafenib plus trametinib. Tumor volume, histology, proliferation, apoptosis, and changes in expression or activation of key components of the MAPK-signaling pathway and other potential biomarkers of resistance will be assessed at each time point.
Primary Objective:
-
Identify markers of intrinsic resistance to B-RAF targeted therapy in B-RAF mutation-positive melanoma.
Secondary Objectives:
-
Determine if intrinsic resistance can be reversed by MEK targeted therapy and to identify biomarkers that correlate with this response.
-
Evaluate the feasibility of presurgical targeted therapy and serial tumor biopsies in patients with advanced, operable melanoma to determine if this model can be used to evaluate novel combinations of molecular targeted therapy in the future.
Exploratory Objective:
-
Determine if presurgical B-RAF and MEK targeted therapy is active and well tolerated in patients with advanced, operable melanoma. These findings may be used to support clinical trials in unresectable, B-RAF mutation-positive melanoma.
Contact: VICC Clinical Trial Information Program • 800-811-8480
ClinicalTrials.gov Identifier: NCT01701037
The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.
For more information on specific trials, including patient selection criteria, please use the contact information listed with each study.
For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at NCCN.org/clinical_trials/clinicians.asp.
