Medical Professionals

For Medical Professionals - GOG-3003

GOG-3003 Trial

GOG-3003 Trial Design

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination with Pegylated Liposomal Doxorubicin (PLD) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Trial Design for GOG-3003 for Ovarian Cancer

Primary Endpoint:

  • Overall survival

Key Secondary Endpoint:

  • Progression-free survival

Key Inclusion Criteria:

  • Recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • 1 of the following histologic cell types: serous, endometrioid, mucinous, undifferentiated, clear cell, mixed epithelial adenocarcinoma, transitional cell carcionoma, malignant Brenner's tumor or adenocarcinoma not otherwise specified
  • Measurable disease: ≥ 1 target lesion per RECIST 1.1 on screening CT or MRI
  • Treatment of primary disease with platinum-based chemotherapy
  • Platinum-resistant disease: progression < 12 months after completing first or second-line platinum-based chemotherapy
  • GOG performance status of 0 or 1

Study Rationale:

Certain chemotherapies, such as PLD, kill cells in a way that can help stimulate immune responses to liberated tumor debris. Motolimod has been shown to clearly increase the activity of PLD in an experimental model of ovarian cancer. This enhancement is associated with the production of various inflammatory mediators, and has been shown to help prime the adaptive T-cell response to the ovarian cancer.

For Additional Information:

For a complete list of active GOG-3003 sites, please visit www.clinicaltrials.gov.