Oncology Research Program

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 studies funded through the grant mechanism are highlighted below.

A Randomized Phase 2 Study of Single-Agent GSK2118436 (BRAFi) vs. Combination Regimen GSK2118436 (BRAFi) and GSK1120212 (MEKi) in Patients With BRAF-Mutated Thyroid Carcinoma

Protocol Chair: Manisha Shah, MD

Institutional Principal Investigators: Manisha Shah, MD; Douglas Ball, MD; Naifa L. Busaidy, MD; and Lori Wirth, MD

Condition: Metastatic thyroid carcinoma

Institutions: The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute; Johns Hopkins University; Massachusetts General Hospital; and The University of Texas MD Anderson Cancer Center

This multi-institutional, randomized phase 2 trial studies how well dabrafenib works with or without trametinib for patients with metastatic thyroid carcinoma. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether dabrafenib is more effective when given with or without trametinib in thyroid carcinoma.

Patients will be randomized to either Arm A or Arm B. In Arm A, patients receive dabrafenib orally 2 twice a day on days 1 through 28. Patients with disease progression may cross over to Arm B. Arm B will receive dabrafenib orally twice a day and trametinib orally once a day on days 1 through 28.

Primary Objective:

  • To screen 2 different regimens, dabrafenib (BRAFi) as a single agent versus the combination regimen of BRAFi and trametinib (MEKi), and identify which regimen is more promising for subsequent testing in a phase III trial in patients with radioiodine-refractory BRAF-mutated differentiated thyroid carcinoma (DTC).

Secondary Objectives:

  • To understand the duration of objective response, progression-free survival, and overall survival for each treatment group.

  • To assess the tolerability and adverse events of BRAFi as a single agent and the tolerability and adverse events of BRAFi and MEKi in combination in patients with DTC.

  • To evaluate the impact of experimental drugs on the serum tumor marker thyroglobulin and its correlation with overall response rate.

  • To understand the pharmacokinetics, pharmacogenetics, and of pharmacodynamics experimental drugs using serial tumor biopsies, tumor blocks, and peripheral blood.

Contact:

Ohio State University Medical Center • 1-800-293-5066 • Jamesline@osumc.edu

Manisha Shah, MD • 614-293-8629 • manisha.shah@osumc.edu

ClinicalTrials.gov Identifier: NCT01723202

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.

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