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.

An NCCN study funded through the grant mechanism is highlighted below.

Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha–Expressing, Triple-Negative Breast Cancer With Residual Disease Post Standard Neoadjuvant Chemotherapy

Principal investigator: Kimberly Blackwell, MD

Sub-investigators: Sarah Sammons, MD; Paul Kelly Marcom, MD; Kelly Westbrook, MD; and Gretchen Kimmick, MD

Condition: Breast cancer

Institution: Duke Cancer Institute

This pilot study is designed to describe changes in folate receptor alpha (FRα) expression after treatment with standard neoadjuvant chemotherapy (NAC) and then 2 doses of mirvetuximab soravtansine in subjects with FRα-positive triple-negative breast cancer (TNBC) with residual disease (RD) following NAC. This study will also evaluate the safety and feasibility of giving 2 doses of mirvetuximab soravtansine after completion of standard NAC and will evaluate other biomarkers in tissue (Ki-67, percent of apoptotic cells, distribution of mirvetuximab soravtansine) and radiologic response. Tissue will be evaluated at the following 3 time points:

  • At diagnosis (before initiation of NAC)

  • After completion of NAC (biopsy of RD)

  • At definitive surgery (after mirvetuximab soravtansine)

Primary Objective:

  • Describe changes in FRα expression after treatment with standard NAC and then 2 doses of mirvetuximab soravtansine in subjects with FRα-positive TNBC with RD after NAC

Secondary Objectives:

  • Evaluate to safety and feasibility of giving 2 doses of mirvetuximab soravtansine after completion of standard NAC

  • Estimate the radiologic response rate after 2 doses of mirvetuximab soravtansine given after completion of standard NAC

  • Describe the association between FRα expression and radiologic response to mirvetuximab soravtansine

  • Describe changes in Ki-67 and percent of apoptotic cells after treatment with standard NAC and then 2 doses of mirvetuximab soravtansine

Contact: Kimberly Blackwell, MD • 919-668-1748 during regular business hours • 919-970-0105 after hours and on weekends and holidays • kimberly.blacwell@duke.edu

ClinicalTrials.gov Identifier: NCT03045393

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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