Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Linda R Duska
Study ID
NCT02635360
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
  • Brachytherapy — RADIATION
    Radiation is done for standard clinical care purposes.
  • Cisplatin — DRUG
    40 mg of chemotherapy drug will be given weekly for 5-6 weeks.

Study Details

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.

Key Dates

Start date
Feb 9, 2017
Status verified
Jun 2025
Primary completion
Jan 1, 2021
Completion
Dec 14, 2022

Study Design

Enrollment
94 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Immunologic Markers Following Combination of Study Drug With Chemoradiation [ Time Frame: 12 weeks post-chemoradiation ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of South Alabama Mitchell Cancer InstituteMobileAlabama36604-
Johns HopkinsBaltimoreMaryland21287-
Washington University, School of MedicineSt LouisMissouri63108-
Levine Cancer InstituteCharlotteNorth Carolina28204-
University of OklahomaOklahoma CityOklahoma73104-
University of VirginiaCharlottesvilleVirginia22908-
INOVA Fairfax HospitalFalls ChurchVirginia22042-
Virginia Commonwealth UniversityRichmondVirginia23298-

Related coverage on Hipa.ai

Find similar trials in Mobile, AL

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of South Alabama Mitchell Cancer Institute· Mobile, ALJohns Hopkins· Baltimore, MDWashington University, School of Medicine· St Louis, MOLevine Cancer Institute· Charlotte, NCUniversity of Oklahoma· Oklahoma City, OKUniversity of Virginia· Charlottesville, VA

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