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.

This feature highlights an NCCN study funded through the grant mechanism.

A Phase I Dose-Escalation Safety and Tolerability Study of Mirvetuximab Soravtansine and Gemcitabine in Patients With Recurrent FRα-Positive Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple-Negative Breast Cancer

Principal Investigator: Mihaela Cristea, MD

Sub-Investigators: Edward Wang, MD; Daphne Stewart, MD; Mark T, Wakabayashi, MD, MPH; Ernest Soyoung Han, MD, PhD; Thanh H. Dellinger, MD; Stephen J. Lee, MD; Lorna Rodriguez, MD, PhD; Alexander Jung, MD; Sharon Wilczynski, MD; Michael Tran, MD; Gottfried E. Konecny, MD; and Joanne Mortimer, MD

Conditions: Recurrent folate receptor α–positive, triple-negative breast carcinoma, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma, and uterine corpus carcinoma

Institution: City of Hope National Medical Center

This phase I trial evaluates the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of mirvetuximab soravtansine (IMGN853) in combination with gemcitabine hydrochloride in patients with relapsed folate receptor α (FRα)–positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple-negative breast cancer (TNBC). This trial also evaluates the efficacy and toxicity of this regimen in 3 expanded cohorts of patients with FRα-positive eligible tumor types (the same as included in the phase I).

Primary Objective:

• Determine MTD and RP2D of gemcitabine when given in combination with IMGN853 to patients with recurrent FRα-positive ovarian, primary peritoneal, fallopian tube, TNBC, or endometrial cancer

Secondary Objectives:

  • Explore toxicity, response rate, and progression-free survival in 3 expanded cohorts of heavily pretreated patients with FRα-positive (1) TNBC, (2) endometrial cancer, or (3) ovarian, primary peritoneal, or fallopian tube cancer, all treated at the RP2D
  • Provide additional safety data from the expanded cohorts to help inform on the RP2D for each cohort
  • Evaluate the relationship between intratumoral levels of DM4, tumoral expression of FRα, and plasma concentration of DM4 at 48 and 72 hours following the first dose
  • Determine the pharmacokinetics of DM4 and gemcitabine when given in combination

Exploratory Objective:

  • Evaluate the role of archival FRα expression as a substitute for the 48- to 72-hour expression in determining intratumoral concentration of DM4

Contact: Mihaela Cristea, MD • 626-256-HOPE (4673), ext. 85200

ClinicalTrials.gov Identifier: NCT02996825

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For more information on specific trials, including patient selection criteria, 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, go to www.NCCN.org/clinical_trials/clinicians.asp.

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