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

Who is this study for? Adult female patients with Non-Recurrent Cervical Cancer and no history of HIV, Hepatitis B/C, Tuberculosis, or Inflammatory Bowel Disease
Status: Active, not recruiting
Location: See all (8) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• Confirmed cervical cancer.

• Must have adequate organ function.

Locations
United States
Alabama
University of South Alabama Mitchell Cancer Institute
Mobile
Maryland
Johns Hopkins
Baltimore
Missouri
Washington University, School of Medicine
Saint Louis
North Carolina
Levine Cancer Institute
Charlotte
Oklahoma
University of Oklahoma
Oklahoma City
Virginia
University of Virginia
Charlottesville
INOVA Fairfax Hospital
Falls Church
Virginia Commonwealth University
Richmond
Time Frame
Start Date: January 2016
Estimated Completion Date: December 2021
Participants
Target number of participants: 88
Treatments
Experimental: Following chemoradiation
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Experimental: Concurrent to chemoradiation
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Authors
Erin Crane, Julie Schwarz, Jennifer Scalici, Linda Duska, Deborah Armstrong, Katherine Moxley, Emma Fields, Chad Hamilton
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Linda R Duska

This content was sourced from clinicaltrials.gov

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