Clinical Trials /

Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer

NCT02635360

Description:

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.

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer
  • Official Title: A Randomized Phase II Study of Chemoradiation and Pembrolizumab for Locally Advanced Cancer

Clinical Trial IDs

  • ORG STUDY ID: 18472
  • SECONDARY ID: UVA-LACC-PD201
  • NCT ID: NCT02635360

Conditions

  • Cervical Cancer

Interventions

DrugSynonymsArms
PembrolizumabKeytruda, MK-3475Following chemoradiation
CisplatinchemotherapyFollowing chemoradiation

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.

Trial Arms

NameTypeDescriptionInterventions
Following chemoradiationExperimentalSubjects 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
  • Cisplatin
Concurrent to chemoradiationExperimentalSubjects 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
  • Cisplatin

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in immunologic markers following combination of study drug with chemoradiation
Time Frame:At 6 weeks of chemoradiation and 12 weeks post-chemoradiation
Safety Issue:
Description:Expression of immune markers measured at pre and post administration of study drug with chemoradiation will be compared.

Secondary Outcome Measures

Measure:Metabolic Response Rate on PET/CT imaging
Time Frame:12 weeks after chemotherapy
Safety Issue:
Description:
Measure:Incidence of distant metastases
Time Frame:From start of treatment until up to 5 years following end of treatment
Safety Issue:
Description:
Measure:Progression Free Survival
Time Frame:From start of treatment until up to 5 years following end of treatment
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:From start of treatment until up to 5 years following end of treatment
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Linda R Duska

Trial Keywords

  • advanced
  • cervical cancer
  • pembrolizumab
  • chemoradiation
  • immunotherapy

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