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NRG-GY003

NRG-GY003: A Phase II Randomized Trial of Nivolumab with or without Ipilimumab in Patients with Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Principal Investigator/Co-Principal Investigator

Robert A. Burger, M.D./Carol Aghajanian, M.D.

Primary Objectives

To estimate the proportion of patients who have objective tumor response (complete or partial) by modified RECIST 1.1 in patients with persistent or recurrent epithelial ovarian, fallopian tube, primary peritoneal cancers, treated with nivolumab or the combination of nivolumab and ipilimumab and to assess the difference in ORR between patients treated with nivolumab versus those treated with the combination of nivolumab and ipilimumab.

To estimate the PFS hazard ratio for patients treated with nivolumab versus those treated with the combination of nivolumab and ipilimumab. To estimate and compare the duration of OS for patients treated with nivolumab or the combination of nivolumab and ipilimumab. PFS by modified RECIST 1.1 will also be examined. To determine the frequency and severity of adverse events associated with treatment with nivolumab or the combination of nivolumab and ipilimumab as assessed by Common Terminology Criteria for Adverse Events (CTCAE).

Integrated Biomarker:  PD-L1 expression in tumor cells and tumor-infiltrating lymphocytes (TILs) measured by quantitative immunohistochemistry (IHC).  Mandatory research blood samples are obtained at three time points: prior to initiating study treatment, 6 weeks after initiating study treatment and 12 weeks after initiating study treatment.

Patient Population

Patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer with documented disease progression.  All patients must have measurable disease with at least one target lesion to assess response by RECIST 1.1.  Patients are allowed to have received up to three prior cytotoxic regimens for treatment of their epithelial ovarian, fallopian tube, or primary peritoneal cancer. They must have had one prior platinum-based chemotherapeutic regimen for management of primary disease, possibly including intra-peritoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy (maintenance/consolidation) administered after surgical or non-surgical assessment. 

Patients are allowed to have received, but are not required to have received, one or two cytotoxic regimens for management of recurrent or persistent disease. (For the purposes of this study PARP inhibitors given for recurrent or progressive disease will be considered cytotoxic.) If two cytotoxic regimens had been received for management of recurrent or persistent disease, one of these regimens would have had to contain either a platinum or a taxane agent.

Target Accrual

First stage: 48 (24 within each arm); Second stage (if warranted): 48 (24 within each arm); Cummulative: 96

Status

Temporary Closure October 7, 2015

Activated June 29, 2015

Protocol Documents

The protocol and related documents are available at NRG-GY003

Copyright 2017 by NRG Oncology