A Phase II Evaluation of Nivolumab, a Fully Human Antibody against PD-1, in the Treatment of Persistent or Recurrent Cervical Cancer
Principal Investigator
Alessandro Santin, MD
Status
Terminated
Date Opened To Accrual
May 18 2015
Date Closed to Accrual
June 08 2016
Date of Study Termination
February 14 2020
Disease Site
Gynecologic [GY]
Cervix
Phase
II
Developmental Therapeutics
No
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
12
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.