A Phase I Trial of Sequential Ipilimumab After Chemoradiation for the Primary Treatment of Patients with Locally Advanced Cervical Cancer Stages IB2/IIA with Positive Para-aortic Lymph Nodes and Only Stage IIB/IIIB/IVA with Positive Lymph Nodes
Principal Investigator
Jyoti Mayadev, MD
Status
Terminated
Date Opened To Accrual
October 01 2012
Date Closed to Accrual
February 12 2017
Date of Study Termination
July 17 2020
Disease Site
Gynecologic [GY]
Cervix
Phase
I
Developmental Therapeutics
No
Primary Objective
To estimate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of adjuvant ipilimumab following concurrent weekly cisplatin and extended field radiation in women with newly diagnosed locally advanced cervical cancer Stage IB2/ IIA with-positive para-aortic lymph nodes only and Stage IIB/ IIIB/ IVA with positive lymph nodes.
To determine the feasibility of the treatment regimen over the four cycles of adjuvant ipilimumab once the MTD is estimated.
To assess the toxicities of the treatment regimen per the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Patient Population
Women with newly diagnosed locally advanced cervical cancer Stage IB2/ IIA with-positive para-aortic lymph nodes only and Stage IIB/ IIIB/ IVA with positive lymph nodes.
Target Accrual
24
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.