Gynecologic

General Information



A randomized Phase II study of chemoradiation and pembrolizumab for locally advanced cervical cancer


Adult


NCT02635360


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.


3289 Woodburn Rd Suite 320
Annandale, VA 22003


Eligibility Information

  • Confirmed cervical cancer.
  • Must have adequate organ function.

Ineligibility Information

  • 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.

Contact Information


Stacey Banks, BA, CCRC


703-970-6553


stacey.banks@inova.org

Additional information can be found at https://clinicaltrials.gov/ct2/show/study/NCT02635360