NRG-GY002: A Phase II Evaluation of Nivolumab, a Fully Human Antibody against PD-1, in the Treatment of Persistent or Recurrent Cervical Cancer

Principal Investigator/Co-Principal Investigator

Alessandro D. Santin, M.D./Michael Fromovitz, M.D., M.P.H.

Primary Objective

To assess the antitumor activity (proportion of objective response by RECIST 1.1 criteria) of Nivolumab with objective tumor response in patients with persistent, recurrent or metastatic carcinoma of the cervix, and to determine the nature and degree of toxicity of nivolumab as assessed by CTCAE.

Patient Population

Patients with persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix with documented disease progression.  All patients must have measurable disease with at least one target lesion to assess response by RECIST 1.1.  Patients must have had one, and only one, prior systemic chemotherapeutic regimen for management of persistent, recurrent or metastatic carcinoma of the cervix. Chemotherapy administered concurrent with primary radiation, or adjuvant chemotherapy given following the completion of radiation therapy, is not counted as a systemic chemotherapy regimen.

Target Accrual

First stage: 12; Second stage (if warranted): 13


Closed June 8, 2016

Reactivated April 25, 2016

Temporarily Closed August 24, 2015

Activated May 18, 2015

Protocol Documents

The protocol and related documents are available at NRG-GY002 (Enter CTEP IAM credentials to access NRG Oncology Member Login)


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