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Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer

This study is currently recruiting participants.
Verified July 2017 by Linda R Duska, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT02635360
First Posted: December 18, 2015
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Linda R Duska, University of Virginia
  Purpose
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.

Condition Intervention Phase
Cervical Cancer Drug: Pembrolizumab Radiation: Brachytherapy Drug: Cisplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Chemoradiation and Pembrolizumab for Locally Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Linda R Duska, University of Virginia:

Primary Outcome Measures:
  • Change in immunologic markers following combination of study drug with chemoradiation [ Time Frame: At 6 weeks of chemoradiation and 12 weeks post-chemoradiation ]
    Expression of immune markers measured at pre and post administration of study drug with chemoradiation will be compared.

  • Incidence of dose limiting toxicities [ Time Frame: From start of treatment until 12 weeks post-chemoradiation ]

Secondary Outcome Measures:
  • Metabolic Response Rate on PET/CT imaging [ Time Frame: 12 weeks after chemotherapy ]
  • Incidence of distant metastases [ Time Frame: From start of treatment until up to 5 years following end of treatment ]
  • Progression Free Survival [ Time Frame: From start of treatment until up to 5 years following end of treatment ]
  • Overall Survival [ Time Frame: From start of treatment until up to 5 years following end of treatment ]

Estimated Enrollment: 88
Study Start Date: January 2016
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Pembrolizumab
200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Other Names:
  • Keytruda
  • MK-3475
Radiation: Brachytherapy
Radiation is done for standard clinical care purposes.
Other Name: chemoradiation
Drug: Cisplatin
40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
Other Name: chemotherapy
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.
Drug: Pembrolizumab
200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Other Names:
  • Keytruda
  • MK-3475
Radiation: Brachytherapy
Radiation is done for standard clinical care purposes.
Other Name: chemoradiation
Drug: Cisplatin
40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
Other Name: chemotherapy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635360


Contacts
Contact: Amy Camblos 434-243-1927 amycamblos@virginia.edu
Contact: Linda Duska lduska@virginia.edu

Locations
United States, Alabama
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36604
Contact: Joanie Broemmelsiek    251-445-9866    jbroemmelsiek@health.southalabama.edu   
Contact: Tammy Mitchem-Welch    251-445-9649    twelch@health.southalabama.edu   
Principal Investigator: Jennifer Scalici, MD         
United States, Missouri
Washington University, School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Jehan Ganachaud, M.Sc.    314-747-9202    ganachaud.j@wustl.edu   
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Heather Neagle, RN, BSN    980-442-2303    Heather.Neagle@Carolinashealthcare.org   
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Jessica Grady    843-792-6969    grady@musc.edu   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sheena Clift    434-924-2745    SHC2WN@hscmail.mcc.virginia.edu   
Principal Investigator: Linda Duska, MD         
INOVA Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Kelly Jeffords    703-208-6606    Kelly.Jeffords@inova.org   
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Melanie R Hamilton       mrhamilton2@vcu.edu   
Sponsors and Collaborators
Linda R Duska
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Linda Duska, MD University of Virginia
  More Information

Responsible Party: Linda R Duska, Associate Professor, Division of Gynecology Oncology, University of Virginia
ClinicalTrials.gov Identifier: NCT02635360     History of Changes
Other Study ID Numbers: 18472
UVA-LACC-PD201 ( Other Grant/Funding Number: Merck Sharp & Dohme Corp. )
First Submitted: December 4, 2015
First Posted: December 18, 2015
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Linda R Duska, University of Virginia:
advanced
cervical cancer
pembrolizumab
chemoradiation
immunotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Pembrolizumab
Antineoplastic Agents


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