NCT02635360

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 9, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

December 4, 2015

Results QC Date

April 7, 2025

Last Update Submit

June 16, 2025

Conditions

Cervical Cancer

Keywords

advancedcervical cancerpembrolizumabchemoradiationimmunotherapy

Outcome Measures

Primary Outcomes (2)

  • Change in Immunologic Markers Following Combination of Study Drug With Chemoradiation

    Expression of immune markers measured at pre and post administration of study drug with chemoradiation will be compared, analyzed and enumerated using QuPath software to provide a cell #/mm2 (not per high power field) and the ratio of CD8+ cells:FoxP3+ cells/mm2 was calculated.

    12 weeks post-chemoradiation

  • Number of Participants With Dose Limiting Toxicities

    To determine the safety of concurrent chemoradiation in combination with pembrolizumab for the treatment of locally advanced cervical cancer

    From start of treatment until 12 weeks post-chemoradiation

Secondary Outcomes (4)

  • Metabolic Response Rate on PET/CT Imaging

    12 weeks after chemotherapy

  • Incidence of Distant Metastases

    From start of treatment until up to 5 years following end of treatment

  • Progression Free Survival

    From start of treatment until up to 5 years following end of treatment

  • Overall Survival

    From start of treatment until up to 5 years following end of treatment

Study Arms (2)

Following chemoradiation

EXPERIMENTAL

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.

Drug: PembrolizumabRadiation: BrachytherapyDrug: Cisplatin

Concurrent to chemoradiation

EXPERIMENTAL

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.

Drug: PembrolizumabRadiation: BrachytherapyDrug: Cisplatin

Interventions

PembrolizumabDRUG

200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.

Also known as: Keytruda, MK-3475
Concurrent to chemoradiationFollowing chemoradiation
BrachytherapyRADIATION

Radiation is done for standard clinical care purposes.

Also known as: chemoradiation
Concurrent to chemoradiationFollowing chemoradiation
CisplatinDRUG

40 mg of chemotherapy drug will be given weekly for 5-6 weeks.

Also known as: chemotherapy
Concurrent to chemoradiationFollowing chemoradiation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Washington University, School of Medicine

St Louis, Missouri, 63108, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 33581976DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

pembrolizumabBrachytherapyChemoradiotherapyCisplatinDrug Therapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsCombined Modality TherapyChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title
Dr. Linda R. Duska
Organization
University of Virginia
LRD5D@uvahealth.org
434-944-9135

Study Officials

  • Linda Duska, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Division of Gynecology Oncology

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 18, 2015

Study Start

February 9, 2017

Primary Completion

January 1, 2021

Study Completion

December 14, 2022

Last Updated

July 3, 2025

Results First Posted

July 3, 2025

Record last verified: 2025-06

Locations

US(8)