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 Phase II Trial of Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAF V600E/K Mutation

Principal Investigator: Paul Chapman, MD

Condition: Melanoma

Institution: Memorial Sloan-Kettering Cancer Center

Inhibition of BRAF V600E kinase has emerged as an effective therapeutic strategy for patients with metastatic melanoma harboring a BRAF V600E mutation. It is reasonable to speculate that BRAF V600E kinase inhibitors will benefit patients with molecularly selected melanoma at earlier stages of the disease. Patients with stage IIIC melanoma have an extremely high risk of disease recurrence and death despite definitive surgical resection. In this single-center phase II trial, patients with surgically resected stage IIIC melanoma characterized by a BRAF V600E or BRAF V600K mutation will be treated with 4 cycles of adjuvant dabrafenib and monitored clinically and radiographically for disease recurrence for 24 months.

Primary Objective:

  • Determine the relapse-free survival at 24 months for patients with stage IIIC melanoma harboring a BRAF V600E/K mutation who are treated with definitive surgical resection followed by 4 cycles of adjuvant dabrafenib administration

Secondary Objective:

  • Determine overall survival

Exploratory Objectives:

  • Characterize the genetic heterogeneity of BRAF-mutated melanomas and explore mechanisms of intrinsic and acquired resistance to dabrafenib

  • Evaluate the ability of circulating tumor-derived exosomes to predict melanoma recurrence

Contacts: Paul Chapman, MD • 646-888-4162

Jedd Wolchok, MD, PhD • 646-888-2395

ClinicalTrials.gov Identifier: NCT01682213

Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma

Principal Investigator: Nikhil I. Khushalani, MD

Condition: Unresectable stage III and stage IV melanoma

Institution: Roswell Park Cancer Institute

This is a phase II study to determine the efficacy and safety of single-agent axitinib in the treatment of patients with advanced melanoma.

Primary Objective:

  • Determine the overall response rate to axitinib in advanced melanoma, assessed using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

Secondary Objectives:

  • Evaluate toxicity of axitinib as a single agent

  • Determine progression-free and overall survivals

  • Explore the utility of fluorothymidine-labeled PET as a predictive marker for response and compare the results with those of standard radiographic imaging

Correlative Science Objectives:

  • Examine the prognostic and predictive significance of circulating melanoma tumor cells

  • Detrermine whether functionally relevant polymorphisms in axitinib-related genes (VEGFR1, VEGFR2, and VEGFR3) correlate with efficacy and toxicity of axitinib in advanced melanoma

Contact: Roswell Park Cancer Institute • (877) 275-7724 • AskRPCI@roswellpark.org

ClinicalTrials.gov Identifier: NCT01533948

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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