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Following chemoradiation for Cervical Cancer
Phase 2
Waitlist Available
Led By Linda Duska, MD
Research Sponsored by Linda R Duska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until up to 5 years following end of treatment
Awards & highlights
Study Summary
This study is evaluating whether immunotherapy can be safely combined with chemoradiation for the treatment of advanced cervical cancer.
Eligible Conditions
- Cervical Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment until up to 5 years following end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until up to 5 years following end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in immunologic markers following combination of study drug with chemoradiation
Incidence of dose limiting toxicities
Secondary outcome measures
Incidence of distant metastases
Metabolic Response Rate on PET/CT imaging
Overall Survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Following chemoradiationExperimental Treatment3 Interventions
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.
Group II: Concurrent to chemoradiationExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Brachytherapy
2007
Completed Phase 3
~2100
Cisplatin
FDA approved
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Who is running the clinical trial?
Linda R DuskaLead Sponsor
1 Previous Clinical Trials
148 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,995 Total Patients Enrolled
Linda Duska, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
148 Total Patients Enrolled
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