Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer

Status:	Recruiting
Conditions:	Cervical Cancer, Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:	Oncology, Reproductive
Healthy:	No
Age Range:	18 - Any
Updated:	8/23/2018
Start Date:	January 2016
End Date:	May 2021
Contact:	Holly Davis
Email:	haw5d@virginia.edu
Phone:	434-243-9553

A Randomized Phase II Study of Chemoradiation and Pembrolizumab for Locally Advanced Cancer

The purpose of this study is to evaluate the safety and effectiveness of immunotherapy in
combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced
cervical cancer. Pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will
be administered after or during chemoradiation.

Inclusion Criteria:

- Confirmed cervical cancer.

- Must have adequate organ function.

Exclusion Criteria:

- Subject is pregnant.

- Recurrent cervical cancer.

- Distant metastases.

- Malignancy within the last 5 years; basal cell carcinoma or squamous cell carcinoma of
the skin that has undergone potentially curative therapy is permissable.

- Subject has had prior radiation, chemotherapy, targeted therapy, or investigational
therapy for cervical cancer.

- Subject has a immunodeficiency.

- Known history of HIV, Hepatitis B, Hepatitis C, TB, or inflammatory bowel disease.

- Hypersensitivity to pembrolizumab or similar drugs.

- Subject has an active autoimmune disease in the past 2 years.

- Known history of non-infectious pneumonitis.

- Subject has an active infection.

- Subject has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects with previously treated brain metastases are permissible. Talk to
Study Contact for specifics.

We found this trial at

sites

University of South Alabama Mitchell Cancer Institute

1660 Springhill Avenue
Mobile, Alabama 36604

(251) 665-8000