GOG-9929

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 Only and Stage IIB/IIIB/IVA with Positive Lymph Nodes

Principal Investigator

Jyoti Mayadev, MD

Status

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

28