Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer
NCT ID: NCT02635360
Last Updated: 2025-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2017-02-09
2022-12-14
Brief Summary
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Detailed Description
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(2) To estimate rates of distant metastasis as the first site of recurrence for patients.
(3) To estimate the influence of concurrent and consolidative MK-3475 on levels of plasminogen activator inhibitor-1 (PAI-1), a marker of immunosuppressive TGF-B.
(4) To estimate the influence of concurrent and consolidative MK-3475 on levels of IDO, an enzyme that depletes tryptophan, which is essential for T-cell function.
(5) To estimate the influence of concurrent and consolidative MK-3475 on levels of MHC class I (CD8+ T cell ligand) and MICA (NK ligand), as measured by MHC.
(6) To estimate the progression free survival (PFS) in subjects with locally advanced cervical cancer treated with sequential and concurrent administration of pembrolizumab in relation to CRT.
(7) To estimate the overall survival (OS) in subjects with locally advanced cervical cancer treated with sequential and concurrent administration of pembrolizumab in relation to CRT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Pembrolizumab
200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy
Radiation is done for standard clinical care purposes.
Cisplatin
40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
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.
Pembrolizumab
200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy
Radiation is done for standard clinical care purposes.
Cisplatin
40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
Interventions
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Pembrolizumab
200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy
Radiation is done for standard clinical care purposes.
Cisplatin
40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have adequate organ function.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Linda R Duska
OTHER
Responsible Party
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Linda R Duska
Associate Professor, Division of Gynecology Oncology
Principal Investigators
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Linda Duska, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Johns Hopkins
Baltimore, Maryland, United States
Washington University, School of Medicine
St Louis, Missouri, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Virginia
Charlottesville, Virginia, United States
INOVA Fairfax Hospital
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Lin AJ, Dehdashti F, Massad LS, Thaker PH, Powell MA, Mutch DG, Schwarz JK, Markovina S, Siegel BA, Grigsby PW. Long-Term Outcomes of Cervical Cancer Patients Treated With Definitive Chemoradiation Following a Complete Metabolic Response. Clin Oncol (R Coll Radiol). 2021 May;33(5):300-306. doi: 10.1016/j.clon.2021.01.010. Epub 2021 Feb 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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UVA-LACC-PD201
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
18472
Identifier Type: -
Identifier Source: org_study_id
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