Principal Investigator/Co-Principal Investigator
Alessandro D. Santin, M.D./Michael Fromovitz, M.D., M.P.H.
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.
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.
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
The protocol and related documents are available at NRG-GY002 (Enter CTEP IAM credentials to access NRG Oncology Member Login)